PC SPES

At this time, 4/2002, PC Spes is not available. There has been a recall of both PC Spes and Spes. To find out more, go to www.psa-rising.com to read updates. June 1, 2002 is now being mentioned as the new availability date. For a history of some of the controversy surrounding PC Spes, see www.psa-rising.com.

While there is now a large number of papers published regarding PC Spes, two recent articles seem especially relevant. One, a paper written by W. Oh, D. George and P. Kantoff(1) documents what happened to the PSA of 4 patients upon stopping PC Spes. The second, an abstract and paper presented at the American Association for Cancer Research meeting held April 6-10, 2002 in San Francisco, CA (see www.aacr.org ) covers the findings of DES, Indomethacin and warfarin in various lots of PC Spes.(2).

The paper by Oh, et al,(1) puts into the medical literature something that most patients on internet forums dealing with PC Spes have known about for some time, i.e., upon stopping PC Spes, a rapid rise of PSA is observed (a so-called cold turkey stopping). The charts for four patients were retrospectively reviewed. All four patients had androgen independent prostate cancer. The rise of PSA was considerably faster after stopping PC Spes than it was while taking PC Spes. PC Spes was discontinued in these 4 men due to a rising PSA. Patient 1(followed June '00 to Feb '01) started at 6 caps/day, then went to 12 caps per day and his PSA had increased 32% to 101ng/dl when he stopped PC Spes. After 6 weeks, PSA was 795% higher and he had increased pain and moved on to estramustine, docetaxel and carboplatin chemotherapy on a clinical trial. Patient 2 (followed Nov '98 to Jan '01) had his PSA drop over 50% upon starting 6 capsules/day followed by slowly rising PSA levels until stopping PC Spes. Upon stopping PSA rose 1300% in 7 weeks and he experienced no new symtoms of pain but moved on to mitoxantrone chemotherapy. Patient 3, was initially diagnosed with metastatic disease, started hormone therapy, failed that, moved on to paclitaxel, estramustine and carboplatin to which he responded well, but he failed that, did ketoconazole, failed that quickly at which time he started 6 capsules/day. His PSA doubled and 2 months later he stopped PC Spes and his PSA levels were up 1400% in 7 weeks. He was still asymptomatic but was then treated wtih estramustine and docetaxel chemotherapy. The last patient, started PC Spes with bone mets and bone pain and took 6 capsules/day with lessened pain and a PSA decline of 71%. Six months later, PSA was rising and he stopped PC Spes and his PSA levels increased by 345%. On restarting PC Spes at 9 capsules/day, PSA levels decreased again by > 75%, then rose over the next eight months at a slow rate. He had stable symptoms during this time.

The authors, in the discussion section, speculate that the rise may represent a flare of disease, but patients 2-4 did not appear to have an increase in tumor volume. They go on to say that it is likely a combination of a release of PSA production(held in check by the PC Spes) and "possibly" a spike in tumor growth.

The paper by Sovak et al (2) at the AACR meeting, probably invalidates many, if not all, of the clinical trials that have been done on PC Spes. Here are some facts from that abstract:

HPLC, proton NMR, GC/MS mass spectra were all used to analyze the samples.
PC-3, DU-145 and LNCaP cell lines were used to evaluate antiproliferative capacity.
Lots tested were manufactured from 1996 to the fall of 2001.
1996 to mid-1999 -- indomethacin = 1.07-13.19 mg/g; DES = 107.28-159.27μg/g.
1996 to mid-1999 -- 2-6x antineoplastic and 14x more estrogenic than lots after mid-1999.
After mid-1999 -- Indomethacin decreased from 1.56 to 0.89mg/g; DES decreased from 46.3 to 0.0 μg/g.
Mid-1999 to the present(fall 2001?) -- warfarin = 341-527 μg/g.

So by the fall of 2001, PC Spes lots at that time had no DES, but 0.89mg/g indomethacin and up to 527 μg/g of warfarin.

One can only speculate as to the efficacy of the "new" PC Spes for hormone refractory prostate cancer. Furthermore, the information below, may or may not be valid in the future.

PC Spes has proven to be an effective therapy for men with hrpc. A starting dose of 9 capsules/day is suggested. Any one dose is effective for 6-7 hours, so the recommended intervals between doses is 6 hours. If you are taking 9 capsules/day, this would translate into, for example, 2 at 4am, 2 at 10am, 2 at 4pm and 3 at 10pm. Avoid food for the two hours prior to taking pc spes and wait until 1-2 hours have passed before eating again. Take with water and drink water as often as you are thirsty.

An excellent review of pc spes trials and their results as well as a list of side effects can be found at:

CA - A Cancer Journal for Clinicians (ACS) http://CAonline.AmCancerSoc.org

and go to this issue:

Terri Ades, RN, MS, AOCN; Ted Gansler, MD; Margie Miller; David S. Rosenthal, MD, "Complemetary & Alternative Methods - PC-SPES: Current Evidence and Remaining Questions," in CA Cancer J Clin 2001;vol. 51, number 3, pp 199-204.

Note: CA Cancer J is a publication of the American Cancer Society.

Numbered References

(1) Oh WK, George DJ, Kantoff PW, "Rapid Rise of Serum Prostate Specific Antigen Levels After Discontinuation of the Herbal Therapy PC-SPES in Patients with Advanced Prostate Carcinoma," Cancer, February 1, 2002, Volume 94, No. 3, pp. 686-689.

(2) Sovak M, Seligson AL, Konas M, Hajduch M, Dolezal M, Machala M, Nagourney R, "PC -SPES in Prostate Cancer: An Herbal Mixture Currently Containing Warfarin and Previously Diethylstilbestrol and Indomethacin,", AACR 2002 Abstract # LB152.