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Impression: The PC-SPES & analogues have an 'adaptogenic effect' This

explains why in some cases testosterone is not completely suppressed (or

suppressed at all for that matter). I have enclosed the text below with [

***** ] to indicate where a mechanistic explanation of this complex activity

is emerging. To fully appreciate the significance of this it is useful to

read the recent Leibowitz paper on 'testosterone therapy' for PC. See

http://www.paactusa.org/newsletters/2003.html or recent EPCEL messages.

 

Comments welcome particularly from our colleagues with experience in TCM.

 

Sammy.

 

 

27 February 2003, Volume 22, Number 8, Pages 1261-1272

 

Oncogenomics - Gene profiling and promoter reporter assays: Novel tools for

comparing the biological effects of botanical extracts on human prostate

cancer cells and understanding their mechanisms of action

 

Dora Bigler1, Kay M Gulding1, Roger Dann2, Fayad Z Sheabar2, Mark R Conaway3

and Dan Theodorescu1

 

1Departments of Molecular Physiology and Biological Physics and Cancer

Center, University of Virginia Health Sciences Center, Charlottesville, VA

22908, USA; 2Kemin Foods, Proteins and Bioassays Development Group, Des

Moines, IA, USA; 3Department of Health Evaluation Sciences (Biostatistics),

University of Virginia Health Sciences Center, Charlottesville, VA, USA

 

Correspondence to: D Theodorescu, Department of Molecular Physiology and

Biological Physics - Box 422, University of Virginia Health Sciences Center,

Charlottesville, VA 22908, USA. E-mail: dt9d

 

Abstract

 

The use of botanical mixtures is commonplace in patients with prostate

cancer, yet the majority of these products have not been rigorously tested

in clinical trials. Here we use PC-SPES, a combination of eight herbs that

has been shown to be effective in clinical trials in patients with prostate

cancer, as a model system to demonstrate 'proof of principle' as to how gene

expression profiling coupled with promoter assays can evaluate the effect of

herbal cocktails on human prostate cancer. In addition, we demonstrate how

such approaches may be used for standardization of herbal extract activity

by comparing the gene profile of PC-SPES with that of PC-CARE, a product

with a similar herbal composition. Since prior studies have shown that

PC-SPES contains estrogenic organic compounds, and such compounds are known

to affect prostate cancer, an important issue is whether these are the

primary drivers of the gene profile.

 

Our data suggest that gene expression profiles of LNCaP human prostate

cancer cells in response to PC-SPES are different from those found when

diethylstilbestrol (DES), a synthetic estrogen, is used, suggesting that the

estrogenic moieties within PC-SPES do not drive this expression signature.

In contrast, the expression profile of PC-CARE was almost identical to that

of DES, highlighting that mixtures containing similar herbal compositions do

not necessarily result in similar biological activities.

 

Interestingly, these three agents cause similar in vitro morphological

changes and growth effects on LNCaP. To validate the expression profiling

data, we evaluated the protein expression and promoter activity of

prostate-specific antigen (PSA), a gene induced by PC-SPES but repressed by

DES.

 

[ *****

 

In order to gain a mechanistic understanding of how PC-SPES and DES affect

PSA expression differently, LNCaP cells were transiently transfected with

wild-type and mutagenized PSA promoter, ARE concatemers and appropriate

controls. We provide evidence that androgen response elements (ARE) II and

III within the promoter region are responsible for the suppressive effects

of DES and stimulatory effects of PC-SPES. In addition, we show that the

effects on PSA transcription are ARE specific in the case of DES while

PC-SPES affects this promoter nonspecifically.

 

***** ]

 

In conclusion, expression profiling coupled with mechanistic target

validation yield valuable clues as to the mode of action of complex

botanical mixtures and provides a new way to compare objectively mixtures

with similar components either for effect or quality assurance prior to

their use in clinical trials.

 

Oncogene (2003) 22, 1261-1272. doi:10.1038/sj.onc.1206242

 

Keywords

 

prostate neoplasms; gene profiling; androgen; estrogen; prostate-specific

antigen/PSA; plant extracts

 

 

Introduction

 

Billions of dollars are spent by American consumers on complementary and

alternative therapies for the treatment of cancer. Unfortunately, the

majority of these products have not been rigorously tested in clinical

trials. In stark contrast, one product stands out both for its clinically

documented effects as well as its popularity among patients. PC-SPES

(Botaniclab, Brea, CA, USA), a combination of eight herbs, has been shown to

decrease prostate-specific antigen levels (PSA) >50% in many patients with

androgen-independent prostate cancer (AIPC) (DiPaola et al., 1998; de la

Taille et al., 2000; Small et al., 2000; Oh et al., 2001). This magnitude of

PSA decrease has in turn been associated with improved survival in clinical

trials (Bubley et al., 1999). Since the current therapy of AIPC does not

lead to cure, the results obtained with PC-SPES offer exciting possibilities

for the development of novel therapies if the active tumoricidal compound

could be identified.

 

In the initial studies on this product, high-performance liquid

chromatography (HPLC), gas chromatography and mass spectrometry showed that

PC-SPES contains estrogenic organic compounds. Since estrogen treatment of

hormone refractory prostate cancer has shown some benefit (Malkowicz, 2001;

Takezawa et al., 2001), the possibility exists that the observed effects of

PC-SPES in prostate cancer are due solely to its estrogenic properties.

Arguing against this hypothesis is the observation that the responses

obtained with PC-SPES exceed those obtained with diethylstilbestrol (DES), a

synthetic estrogen. In a recent clinical trial, 17/38 patients (45%) on

PC-SPES demonstrated a PSA response compared to 8/39 patients (21%) on DES

(Small et al., 2002). Nevertheless, while unlikely, it is still conceivable

that the estrogens in the PC-SPES are more potent than DES and this could

explain the observed clinical results.

 

Likely because of the successful marketing and documented clinical effects

of PC-SPES, products with similar names (i.e. PC-CALM, PC-PLUS and PC-CARE)

and herbal compositions are appearing on the market. However, none of these

products appear to have been studied and reported in the peer-reviewed

scientific literature (White, 2002), yet are likely consumed by many

patients with prostate cancer.

 

Based on these observations, we propose to test the hypothesis that PC-SPES

affects a completely different gene expression repertoire than does DES when

applied to human prostate cancer.

 

The practical importance of such findings is as follows: (1) If the induced

gene profile of this herbal extract were similar to DES, this would lend

support to the notion that the clinical result (Small et al., 2002) was

because of potency differences among the estrogens as speculated above, and

there would be significantly less interest in undertaking the difficult

biochemical fractionation and subsequent screening to identify the exact

chemical compounds responsible for its inhibitory effect on prostate cancer.

(2) If the induced gene profile of this mixture were different from that of

DES, this would suggest that PC-SPES exerts its biological effects

differently from DES, and would pave the way for the development of rational

reporter assays used to evaluate fractions of this mixture with subsequent

identification of the active compound that may lead to a significant

therapeutic advance in prostate cancer. In addition, we seek to use this

approach to compare and contrast two similar herbal mixtures and thus

demonstrate 'proof of principle' of a new paradigm for the 'functional'

standardization of similar botanical products marketed directly to

consumers.

 

 

[ *****

 

Here we use PC-SPES to demonstrate how gene expression profiling coupled

with promoter assays can suggest whether this herbal cocktail exerts its

biological effect on prostate cancer via its estrogenic components or via

completely different pathways.

 

We show that gene expression profiles of human prostate cancer cells in

response to PC-SPES are different from those found when DES is used,

suggesting that the estrogens in this mixture are not the primary effectors

of this gene profile. In contrast, the profiles of PC-CARE are similar to

those of DES indicating that despite similar starting components, botanical

mixtures can have profoundly different biological effects. In addition, we

use prostate-specific antigen (PSA) expression and promoter mutants of this

gene in human prostate cancer cells to validate the expression profiling

data and to suggest that PC-SPES regulates this gene differently than does

DES.

 

***** ]

 

Results and discussion

 

PC-SPES inhibits tumor growth in vitro and in vivo and is independent of the

androgen sensitivity of the prostate cancer cell lines

 

Ethanol extracts of PC-SPES can significantly reduce LNCaP proliferation

(Hsieh et al., 1997). Although androgen-independent cell lines have been

evaluated for their sensitivity to PC-SPES, a definite conclusion as to the

relation between androgen sensitivity and PC-SPES response cannot be made

because of the differing origins of the various cell lines. To test the

hypothesis that the antiproliferative response to PC-SPES is not a function

of androgen resistance, C4-2, a unique lineage related but

androgen-independent LNCaP derivative, was evaluated and compared to LNCaP.

Examination of the cell morphology in response to PC-SPES, PC-CARE and DES

reveals cellular rounding and increased prominence of nucleoli (Figure 1a).

No difference existed between compounds used on either cell lineage except

for PC-CARE at 1 l/ml, which was associated with no morphological change.

Following incubation with 0, 1, 2 and 5 l/ml of PC-SPES extract for 1-2

days, a dose- and time-dependent growth inhibition was observed and no

difference between LNCaP and C4-2 was found (Figure 1b). Interestingly, 10 M

when we evaluated the effect of 5 l/ml PC-CARE and DES on these two cell

lines, a similar degree of suppression of proliferation to that of PC-SPES

was seen in both cell lines (data not shown).

 

Since the effects of PC-SPES on androgen-dependent LNCaP cells have never

been evaluated in vivo, we used this herbal mixture in a xenograft model.

Feeding male mice PC-SPES resulted in a significant depression of growth for

the whole duration of treatment when compared to vehicle-treated controls.

In addition, growth stabilization of the tumors occurred between 10 and 30

days with a resumption of growth following this period of time, indicating

the possible emergence of a resistant tumor phenotype (Figure 1c). It is

important to note that this is the only currently published animal data with

PC-SPES in which the lot used is known to be free of exogenous DES (Sovak et

al., 2002), yet has a profound effect on xenograft growth.

 

PC-SPES has different HPLC fingerprints when compared to known estrogenic

compounds

 

Because of recent concerns that some lots of PC-SPES contain small amounts

of exogenous estrogens (Small et al., 2002), we tested for the presence of

estrogens and other isoflavones in our lot of PC-SPES. HPLC profile of the

PC-SPES extracted in a fashion similar to that used for in vitro and in vivo

assays was compared to that of various standards. In addition, the spectrum

of various eluting peaks was determined as well. PC-SPES shows a major peak

at 1.6 min (Figure 2a). A minor peak that elutes at 2.6 min appears to

partially coelute with diadzein. When the spectrum under each peak is

compared (Figure 2b), differences are seen between PC-SPES and both

standards, diadzein and 17-estradiol. The primary PC-SPES peak may be

related to diadzein, but is probably not identical. No DES was found on our

lot of PC-SPES confirming previous reports (Sovak et al., 2002).

 

***** Surely good evidence to suggest previous samples were tampered with to

'prove' they were contaminated with conventional drugs and thus explain-away

the success of PC-SPES. Remember the FDA labs found no DES contamination

either - DES was found in samples where independent auditing of procurement

and storage was not made. Moral of the story: " Don't go down 'Skid Row' to

sample a good whiskey " ;-/ *****

 

Prostate cancer cells exposed to PC-SPES exhibit a different gene profile

than cells exposed to PC-CARE and DES

 

Taken together, the data presented above support the notion that PC-SPES and

DES are equally effective at reducing prostate cancer proliferation

irrespective of the cell's androgen-sensitivity status and this is

associated with similar cellular morphological changes. Superficially, these

data could be interpreted as supporting the notion that PC-SPES and DES

affect cell growth via similar mechanisms. However, this notion is

challenged by the findings that PC-SPES shows more favorable results in

patients with prostate cancer than DES (Small et al., 2002). We sought to

test the hypothesis that PC-SPES and DES affect the expression of a similar

repertoire of genes by carrying out gene expression profiling. By analysing

duplicate samples, a stringent statistical analysis aimed at determining the

genes that are differentially expressed in the two groups was carried out.

It is important to note that cellular incubation conditions and timing for

this analysis was carried out in an identical fashion to that used to obtain

the morphological changes shown in Figure 1a. Therefore, any differences in

gene expression in this setting are not because of gross differences in

cellular appearance in response to either PC-SPES or DES.

The genes that were statistically significantly induced or suppressed by

PC-SPES or DES are shown in Table 1. Examination of these data suggests a

strikingly different expression profile between the two tested agents.

Interestingly, PSA expression is significantly changed by both agents but in

the opposite direction. Whereas PC-SPES induces PSA, DES suppresses the

expression of this gene indicating that these compounds have dramatically

different effects on this androgen-responsive gene in human prostate cancer.

In addition, irrespective of the statistical significance of their induction

or suppression by either agent, all the genes with names containing the text

search term 'prostate' found on the chip were listed in Table 2. It is

interesting to note that with the exception of PSA, none of these are

significantly affected by PC-SPES or DES. We have validated the Affymetrix

results using quantitative RT-PCR technology using five genes randomly

picked from those shown in Table 1. As can be seen in Table 3, there is

excellent agreement between Affymetrix 'fold' expression of these five genes

and the 'fold' expression obtained by RT-PCR.

 

In addition to highlighting differences between the gene expression

repertoires in response to various pharmacologic products, gene expression

profiling has two other benefits. First, it can lead to clues as to the

mechanism of action of PC-SPES by identifying the genes, which are induced

by this agent. An examination of Table 1 indicates that several genes

involved in the cell cycle are affected by PC-SPES. Never in mitosis gene a

(NIMA)-related kinase 2 (Helps et al., 2000) is induced by PC-SPES.

Induction of this gene in prostate cancer may be associated with growth

arrest and thus may underlie the mechanism of action of PC-SPES. Another

protein, S100P is a member of the S100 family of proteins containing two

EF-hand calcium-binding motifs. S100 proteins are localized in the cytoplasm

and/or nucleus of a wide range of cells, and are involved in the regulation

of a number of cellular processes such as cell cycle progression and

differentiation.

 

Interestingly, the expression of S100P has previously shown to be

downregulated in LNCaP cells following androgen deprivation (Averboukh et

al., 1996). We are currently evaluating these and several other genes for

their functional roles in prostate growth and progression. After submission

of this manuscript, a study by Bonham et al. (2002) was published profiling

3000 prostate-derived genes in response to PC-SPES and DES. Interestingly,

apart from the general conclusion that the expression profile of PC-SPES is

not similar to that of DES, this manuscript reveals striking differences

from our own, not only in the genes altered by PC-SPES and DES but also in

the direction (up or down) of their regulation. For example, PSA is

downregulated by DES and PC-SPES in their study while it is only

downregulated by DES in our work. In addition, cdc-20, cdc-25B, cyclin A2,

cyclin B2 and MAD2 were upregulated in our study while they were

downregulated in theirs. Several genes including Cyclin E2, cdc-6, tubulin 1

and 2 were downregulated in both studies. The basis for these discrepancies

may be because of several factors including: (1) one of the lots of PC-SPES

used by Bonham et al. contained DES (lot 5431106 (Sovak et al., 2002), which

would explain the PSA expression result among others; (2) the LNCaP cell

line used was sourced differently from our own and phenotypic differences in

this cell line have been reported by various laboratories.

The second benefit of such profiling is in the determination of gene

clusters, which are most specifically affected by either PC-SPES (Figure 3a)

or DES (Figure 3b). These data are complementary to that shown in Table 1

and can be used in future studies to construct custom arrays for several

applications such as quality control assessment of natural products.

Surprisingly, the expression profiling of PC-CARE, which purportedly has the

same starting components as PC-SPES is strikingly different from that of

PC-SPES (Figure 3 and Table 1). This is even more interesting in view of the

fact that the unsupervised cluster analysis and significantly altered genes

shown in Figure 3 and Table 1, respectively, strongly indicate that the

expression profiling of PC-CARE is more closely related to that of DES

rather than that of PC-SPES. This finding has profound implications since it

potentially offers an avenue for the molecular 'fingerprinting' of complex

botanical extracts, which are claimed to be made from the same natural

sources. Application of these approaches in preclinical studies may allow

for both the standardization of the botanical mixtures allowing for rational

interpretation of any discrepant human clinical data. In addition, companies

producing botanical products can use this technology in quality assurance of

their products, which may have biological relevance superior to conventional

approaches such as HPLC.

 

PC-SPES stimulates PSA secretion and PSA promoter activity in the presence

or absence of androgen

 

[ ***** -

 

The chip data above indicate that PSA expression is regulated differently in

response to PC-SPES as compared to DES. PC-SPES induces PSA expression while

DES suppresses this gene indicating that these compounds may have

fundamentally different effects on androgen-responsive genes in prostate

cancer cells. Therefore, we chose PSA as a prototypical model for the study

of androgen-responsive genes in prostate cancer. The availability of

well-defined culture conditions in which androgen stimulation and

deprivation can be evaluated combined with well-characterized promoter

constructs makes this gene ideal for such studies. It is important to note

that in order to fully characterize the effect of PC-SPES and DES on PSA

transcription in both the presence and absence of androgen, we used standard

culture conditions for this specific purpose that are somewhat different

from those used to generate data on the morphological changes and microarray

expression profiles in response to these two agents. Therefore, although

qualitatively similar, results from the microarray data in regard to PSA

cannot be quantitatively compared to those of the promoter reporter studies

described below.

 

Secreted endogenous PSA levels were evaluated in response to synthetic

androgen R1881 stimulation and addition of PC-SPES for 3 days, following a

24 h incubation in serum-free, phenol red-free RPMI medium complemented with

5% charcoal-stripped FBS. This in vitro condition is analogous to PC-SPES

treatment of prostate cancer patients, which have not yet had androgen

ablation and serves to evaluate whether this agent can antagonize the

effects of androgen. Data presented in Figure 4a indicate that PC-SPES

counteracts PSA protein secretion by R1881 and this is dose dependent.

However, these data also indicate that in the absence of androgen, lower

doses of PC-SPES can stimulate PSA secretion.

 

LNCaP cells were transfected with PSA-driven luciferase reporter plasmids

(Figure 4b). After serum starving the cells for 24 h, PSA expression was

induced by adding 1 nM R1881. At the same time, the cells were treated with

various doses of PC-SPES extract or DES and incubated for 3 days. PSA

promoter induction with R1881 was inhibited by DES in a dose-dependent

manner (Figure 4c). In contrast, in uninduced cells (no R1881) PC-SPES

itself seems to have an inducing effect at the 1.5 l/ml dose, which was

still manifest in the context of R1881 addition. At higher doses the

stimulating effect of R1881 on the PSA promoter was reduced by PC-SPES. When

the levels of secreted PSA and those of PSA promoter activity are compared

(Figure 4a and c), it becomes apparent that in the context of androgen,

PC-SPES may diminish PSA secretion while having the opposite effect on PSA

promoter activity suggesting that PC-SPES may function by inhibiting

post-transcriptional events of the PSA gene in certain situations and at

certain doses.

 

PC-SPES and DES have opposite effects on PSA expression and this is mediated

by ARE-II and III

 

DES and PC-SPES have strikingly different dose-dependent effects on the

whole PSA promoter both in the absence and presence of R1881 (Figure 4c). In

contrast to PC-SPES, DES shows a definitive inhibition of androgen

stimulated PSA expression at all doses (Figure 4c). While DES has been shown

not to modulate mRNA expression of two androgen-responsive genes, C3 and

SGP-2, in the prostate (Turner et al., 2001), it does not appear to bind to

the androgen receptor directly (Montgomery et al., 1992) and thus its exact

mechanism of action is unclear.

 

Upon binding to androgen, the androgen receptor translocates into the

nucleus and binds to three androgen-response elements (AREs) on the PSA

promoter, where it interacts with other transcription factors and activates

PSA gene transcription. In cells transfected with a construct containing

three concatemerized copies of the PSA ARE I (Cleutjens et al., 1997),

PC-SPES appears to have a nonspecific stimulatory effect as indicated by its

similar pattern of induction of both the ARE-I and control contructs. The

presence of androgen marginally increased the nonspecific stimulation

(Figure 4d). In contrast, DES shows an ARE-I-specific inhibition of

R1881-stimulated reporter activity similar in pattern to that observed with

the whole PSA promoter (Figure 4c), suggesting that DES exerts its effect on

PSA specifically via this ARE while PC-SPES does this via nonspecific

effects on ARE I.

 

To further investigate the role of the individual AREs in the overall and

androgen-induced transcriptional responsiveness of the 6-kb PSA promoter in

the context of PC-SPES and DES, we used knockout mutations introduced for

each individual ARE in the full-length PSA promoter (Figure 4b). Cleutjens

et al. (1996,1997) identified three consensus AREs within the 5.8-kb PSA

promoter. ARE I and II are located within the proximal region of the

promoter, whereas ARE III is contained within a 440-bp strong enhancer

element core (AREc) located at -4.2 kb on the promoter. Transient

transfection of LNCaP cells with the resulting mutated PSA promoter-LUC

constructs showed that ARE II and III contributed to both the stimulatory

and inhibitory effects of PC-SPES and DES, respectively (Figure 4e). These

findings indicate that ARE-II and III are key elements in PSA promoter

regulation by PC-SPES and by DES in the context of androgen stimulation. In

addition, the reduction of PSA transcriptional activity seen with the

wild-type promoter (Figure 4c) at higher PC-SPES doses is lost with the

mutated full-length constructs (Figure 4e) and the ARE I concatemer (Figure

4d) indicating the presence of complex yet undefined ARE-dependent

regulatory events.

 

Materials and methods

 

Cell lines, in vitro morphology, growth curves and PSA secretion

 

Human prostate cancer cell lines LNCaP and C4-2 were obtained from Dr L

Chung, Department of Urology, Emory University. C4-2 is an

androgen-independent cell line derived from androgen-sensitive LNCaP cells

(Wu et al., 1994). Unless otherwise specified, cells were grown and all

experiments were carried out in T-media, containing 5% fetal calf serum

(FCS). Both cell lines are tumorigenic and produce prostate-specific antigen

(PSA) (Wu et al., 1994). Morphology of cells was assessed microscopically

after 24 h of treatment with either 1 l/ml PC-SPES, 1 or 5 l/ml PC-CARE, 10

M DES or with 5 l/ml 70% EtOH as control. Growth curves were generated by

the evaluation of cell numbers at various time intervals by the SyberGold

Assay (Molecular Probe, Eugene, OR, USA) performed according to the

manufacturer's protocol. For secreted, endogenous PSA levels LNCaP cells

were grown for 24 h in phenol red-free RPMI medium complemented with 5%

charcoal-stripped FBS before induction with R1881 and addition of PC-SPES.

At 3 days after induction, the medium was evaluated for PSA by the

University of Virginia Medical Laboratories using the Olympus AU640 analyzer

and reagents (Olympus Diagnostics Systems).

 

Preparation of PC-SPES and PC-CARE extracts

 

PC-SPES was obtained from BotanicLab Inc. (Brea, CA, USA) via direct

purchase from their website (www.botaniclab.com) in April 2001. The PC-SPES

(lot 5431219) used for these experiments does not contain any exogenous DES

(Sovak et al., 2002). PC-Care (Natrol, Chatsworth, CA, USA) was obtained on

June 2001 via direct web site purchase (www.drugstore.com). Stock solutions

were prepared by suspending the content of one capsule in 1 ml of 70% EtOH,

stirring the suspension for 1 h at room temperature and removing the

insoluble material by centrifugation as previously described (Darzynkiewicz

et al., 2000). The clear 70% EtOH extract was filtered through a 0.22 m

Millipore filter and stored in small aliquots at -20?C. Synthetic androgen

R1881(Cleutjens et al., 1997) and estrogen diethylstilbestrol (DES) were

purchased from Sigma.

 

HPLC and spectroscopy

 

In view of the known estrogenic compounds found in PC-SPES (DiPaola et al.,

1998), two standards were used for the HPLC: 17-estradiol and diadzein. Two

standards were prepared by dissolving <0.5 mg in 50:50 H2O:ACN (1 ml).

Various amounts were chromatographed by HPLC (Hewlett-Packard 1100 series)

equipped with a Diod Array Detector on a C18 column, 4.6?250 mm 100 A pore

size, 5 M particles (Varian Inc.) at 25?C and an isocratic gradient of 50:50

H2O:ACN at a flow rate of 1 ml/min. PC-SPES samples were prepared by

suspending the content of two capsule in EtOH followed by vigorous mixing

and centrifugation at 6000 r.p.m. The supernatant was dried under nitrogen

flow and redissolved in 50:50 H2O:ACN (1.5 ml mobile phase, and diluted

1:1).

 

In vivo tumor growth and statistical analysis

 

Nude male mice, 6 week old, were obtained from Taconic farms and maintained

strictly according to the NIH and institutional guidelines at the University

of Virginia animal facility. A total of 5?106 LNCaP cells in 0.1 ml Matrigel

were injected subcutaneously in each animal. At 4 weeks after injection, the

mice were randomly divided into a group of 20 mice that received PC-SPES and

a group of 20 mice that received the carrier only. PC-SPES was administered

orally (gavage) at a concentration of 250 mg/kg/day as previously described

(Kubota et al., 2000). Mice were weighed every week and tumor sizes were

measured twice a week as described (Seraj et al., 2000). Mice were

euthanized 40 days postinjection. Two-sample t-tests were used to compare

average tumor volumes between groups on each day. More sophisticated

analyses using repeated measures models yielded nearly identical results,

and we present the results from the simpler analyses based on t-tests.

 

PSA reporter constructs and transient transfections

 

All plasmid DNA used for transfection was prepared by the 'EndoFree Plasmid

Maxi kit' from Qiagen (Valencia, CA, USA) following the manufacturer's

protocol. The various PSA promoter constructs were a gift from Dr Michael

Weber (University of Virginia). The 6 kb promoter fragment (whole PSA

promoter) in pGL3 basic, 3ARE-I-TATA (from PSA and TK promoters,

respectively), ARE minimal sequence - TATA and TATA only control constructs

were previously described (Cleutjens et al., 1996,1997). The ARE I-1, ARE

II-1 and ARE III-1 mutant constructs are point mutants in the three

different ARE motifs at position -170 bp (ARE I), -394 bp (ARE II) and -4200

kb (ARE III), respectively, in the context of the whole PSA promoter and

have been previously described (Cleutjens et al., 1996,1997).

 

DNA transfection was performed using the lipofectin method (Invitrogen, Palo

Alto, CA, USA) as described by the manufacturer. Cells were plated at a

density of 1.5?105 cells/ml in six-well plates and fed the next day.

Transfection was performed the day after and the cells were allowed to

recover in T-media containing 5% FBS. After 24 h, the medium was switched to

serum-free, phenol red-free RPMI medium complemented with 5%

charcoal-stripped FBS for another 24 h before PSA-driven reporter expression

was induced by adding the synthetic androgen R1881 at a final concentration

of 1 nM. Where indicated, PC-SPES or DES was added at the time of induction.

After 72 h cells were harvested, washed in PBS and lysed in 400 l Reporter

Lysis Buffer (Promega, Madison, WI, USA). Lysed samples were analysed in a

Turner Designs Luminometer by adding 20 l cell lysate to 100 l Luciferase

Assay Reagent. Luciferase activity was corrected for cell number, determined

with the SyberGold assay mentioned above.

 

Affymetrix chip processing and analysis

 

LNCaP cells were treated with 1 l/ml PC-SPES, 1 and 5 l/ml PC-CARE, 10 M DES

or with 5 l/ml 70% EtOH as control and grown for 24 h. This experiment was

repeated with completely different cells one week after the initial

experiment. RNA was extracted at the end of the 24 h incubation period with

the Qiagen RNeasy kit (Qiagen, San Diego, CA, USA). Microarray analysis was

performed as described in the manufacturer's instructions (Affymetrix, Santa

Clara, CA, USA). Briefly, cRNA was prepared from 8 g of total RNA,

hybridized to HG-U95AV2 Affymetrix oligonucleotide arrays, which contain

approximately 12 000 human genes or ESTs. After washing in a fluidic

station, the arrays were scanned with a 2.5 m resolution HP Microarray

Scanner (Hewlett Packard). Scanned images were first examined for visible

defects and then checked for the fitness of the gritting. When passed, the

image file was analysed to generate a raw data file named cell files.

 

From this point on, a coordination of two paths of analysis was carried on

using the Affymetrix Microarray Analysis Suite 5.0 (MAS 5.0, Affymetrix) and

the Dchip software (Schadt et al., 2000,2001; Li and Wong, 2001). The

detection of a particular gene, present, absent or marginal, was made using

the MAS 5.0, those detection calls were later imported into and utilized by

the Dchip program. Scatter plots were also generated using this software to

inspect the reproducibility of the duplicates or the degree of changes among

samples. Quantitation of the genes was obtained using the Dchip, which

applied the model-based approach to derive the probe sensitivity index and

expression index. The two indices were combined to quantify a particular

gene. When certain probes or transcrips deviated from the model to a set

extent, they were excluded from the quantitation process. Normalization of

the arrays was performed using the invariant set approach. Comparative

analysis of the samples using Dchip generated fold changes and paired sample

t-test P-values. Regularly, we consider a P0.05 and a fold change 1.2 in

combination of a % Present 50 as an indication of significant change of gene

expression for upregulation or downregulation. A Spearman correlation

coefficient was generated for all the possible pairs involved using the

Dchip quantitation results for quality control.

 

Filtering of the genes was performed to select the genes for hierarchical

clustering using the build-in module in Dchip. The following criteria were

applied for the filtering process: 0.5s.d./mean 10 AND Present call 25%

among all samples AND Signal intensity 20 in 50% of all samples. Before

clustering, expression values for a specific gene are standardized (linearly

scaled) in all samples to have mean 0 and s.d. 1, and these standardized

values are used to calculate correlations between genes and samples and

serve as the basis for merging nodes. The distance of two neighboring genes

is calculated using the Pearson's correlation model and is expressed as

1-|r|, which would be the length of the stem connecting the two branches.

 

Validation of Affymetrix chip results

 

In order to validate the Affymetrix chip expression data, we have carried

out real-time quantitative RT-PCR for five genes that showed expression

differences in the three experimental groups (Table 1). Suitable probes were

ordered from the Applied Biosystems Assays-on-DemandO Gene Expression

products library, a comprehensive collection of predesigned and functionally

tested assays. Each assay consisted of two unlabeled PCR primers and a FAMO

dye-labeled TaqManO MGB probe. All components are QC tested and formulated

into a single 20x mix. TaqManO Universal PCR Master Mix was added to the

cDNA sample to generate quantitative gene expression data on an Applied

Biosystems ABI PRISMO 7900HT Sequence Detection System.

 

Acknowledgements

The authors thank Drs Jay Fox and Yongde Bao of the University of Virginia

Array Core facility for their assistance with chip hybridization, data

analysis and helpful suggestions.

 

References

 

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Figures

 

Figure 1 PC-SPES effect on LNCaP and C4-2 prostate cell morphology and

growth. (a) Morphology: cells were treated with either 1 l/ml PC-SPES, 5

l/ml PC-CARE, 10 M DES or with 5 l/ml 70% EtOH as control. Pictures were

taken after 24 h incubation. (b) In vitro growth: cells were treated with

either 1, 2 or 5 l/ml PC-SPES or with 5 l/ml EtOH as control and incubated

for 1 and 2 days. The cells were lysed and the relative number of cells

determined by a SyberGold assay, as described in materials and methods.

Error bars represent the s.e. from the mean of quadruplicate sample. Data

are representative for two independent experiments with similar results. ©

In vivo growth: mean changes in tumor volume by day and treatment group. The

errors bars represent 1 s.e. The values along the axis are P-values for

comparing treatment means at each day

Figure 2 Reverse phase HPLC chromatograms of PC-SPEC sample and standards

and their corresponding spectra. PC-SPES was extracted with ethanol and

separated by RP-HPLC. (a) Retention time of various peaks and (b) their

spectra were compared to those of various estrogens or isoflavones

Figure 3 Cluster analysis of PC-SPES, PC-CARE and DES-treated LNCaP cells.

Unsupervised cluster analysis displaying differential gene expression of the

duplicate samples. Hierarchical clustering was performed with the D-Chip

software after filtering the genes with the defined criteria as described in

the materials and methods section. Genes coded in red color are deemed to

have been upregulated and those in blue color downregulated, while those

showing no significant changes are white. The brighter colors signify higher

magnitude in the scale of the changes in either direction. The color bar in

front of a gene name indicates the classification in gene ontology

(www.geneontology.org). Panel (a) shows genes preferentially clustered with

PC-SPES; Panel (b) shows genes preferentially clustered with PC-CARE and

DES. Abbreviations: S: PC-SPES (1 l/ml); C1: PC-CARE (1 l/ml); C5: PC-CARE

(5 l/ml); D: DES (10 M)

Figure 4 The effect of PC-SPES and DES on PSA secretion and expression in

LNCaP cells. (a) Untransfected LNCaP cells were treated as indicated, adding

1 nM R1881 for induction of PSA and at the same time either 0, 0.5 or 1.5

l/ml PC-SPES. The cells were pelleted and the media analysed for secreted

PSA level. (b) Diagrammatic representation of the location of three

consensus AREs (and resultant mutant constructs used in (e)) within the PSA

promoter (Cleutjens et al., 1996,1997). © PSA expression with whole PSA

promoter constructs: LNCaP cells were transiently transfected with whole PSA

promoter pGL3 reporter construct and treated as indicated: adding 1 nM R1881

for induction of PSA and at the same time either 0, 0.5, 1.5 l/ml PC-SPES,

or 0, 10, 20 M DES. The cells were harvested after 3 days and assayed for

luciferase activity. (d) PSA expression with ARE-TATA constructs: LNCaP

cells were transiently transfected with three ARE-I-TATA or TATA only PSA

pGL3 reporter construct and treated as indicated in (a). The suffix 'Ind'.

indicates samples exposed to R1881 while 'Unind'. are samples not exposed to

this agent. (e) PSA expression with ARE mutant constructs: LNCaP cells were

transiently transfected with either AREmin, ARE I, ARE II or ARE III pGL3

reporter construct and treated as indicated in (a). All samples in this

experiment were treated with R1881. Error bars represent the s.e. from the

mean of duplicate samples. Data are representative for two or more

independent experiments with similar results

 

Tables

 

Table 1 Genes on HG-U95AV2 Affymetrix oligonucleotide arrays, which had a

significantly altered expression in PC-SPES, PC-CARE and DES

Table 2 All prostate-related genes on HG-U95AV2 Affymetrix oligonucleotide

arrays

Table 3 Validation of expression of 5 genes from Table 1 using real-time

quantitative RT-PCR

 

 

 

Received 22 July 2002; revised 8 November 2002; accepted 12 November 2002

 

27 February 2003, Volume 22, Number 8, Pages 1261-1272

 

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In a message dated 3/5/03 4:21:36 AM Eastern Standard Time,

ga.bates writes:

 

> PC-SPES, a combination of eight herbs that

> has been shown to be effective in clinical trials in patients with prostate

> cancer,

 

I believe that product has been discontinued. I believe the FDA and something

to do with that.

I do not wish to say any more except look at the herbs that were in the

product.

 

Stan

 

 

 

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ga.bates wrote:

>

> Impression: The PC-SPES & analogues have an 'adaptogenic effect' This

 

Can't quite remember exactly what the problem with PC-SPES was, but it

was ultimately taken off the market, I believe it had been laced with

pharmaceuticals to cause the prostate to shrink.

 

Do a search for this product, you'll see that it is no longer available.

 

-al.

 

Al Stone L.Ac.

<AlStone

http://www.BeyondWellBeing.com

 

Pain is inevitable, suffering is optional.

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