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Prostate cancer and blocking testosterone

Use of Androgen blocking treatment not worth the side effects for early prostate cancer, though the medical industry argues otherwise.

Since NJM does not see the raw data, and this study was not used for FDA approval (but for marketing purposes) the reasonable conclusion is that at best there was no improvement in survival for short-term use of androgen blocking treat (ADT)--their finding was a 5% improvement. 

http://www.nejm.org/doi/full/10.1056/NEJMoa1012348?query=TOC

Radiotherapy and Short-Term Androgen Deprivation for Localized Prostate Cancer

Christopher U. Jones, M.D., Daniel Hunt, Ph.D., David G. McGowan, M.B., Ch.B., Mahul B. Amin, M.D., Michael P. Chetner, M.D., Deborah W. Bruner, R.N., Ph.D., Mark H. Leibenhaut, M.D., Siraj M. Husain, M.D., Marvin Rotman, M.D., Luis Souhami, M.D., Howard M. Sandler, M.D., and William U. Shipley, M.D.

N Engl J Med 2011; 365:107-118July 14, 2011

Background

It is not known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.

Methods

From 1994 through 2001, we randomly assigned 1979 eligible patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a prostate-specific antigen (PSA) level of 20 ng per milliliter or less to radiotherapy alone (992 patients) or radiotherapy with 4 months of total androgen suppression starting 2 months before radiotherapy (radiotherapy plus short-term ADT, 987 patients). The primary end point was overall survival. Secondary end points included disease-specific mortality, distant metastases, biochemical failure (an increasing level of PSA), and the rate of positive findings on repeat prostate biopsy at 2 years.

Results

The median follow-up period was 9.1 years. The 10-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving radiotherapy alone (hazard ratio for death with radiotherapy alone, 1.17; P=0.03). The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8% to 4% (hazard ratio for radiotherapy alone, 1.87; P=0.001). Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT. Acute and late radiation-induced toxic effects were similar in the two groups. The incidence of grade 3 or higher hormone-related toxic effects was less than 5%[1]. Reanalysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients, with no significant reductions among low-risk patients.

Conclusions

Among patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less, the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival. According to post hoc risk analysis, the benefit was mainly seen in intermediate-risk, but not low-risk, men. (Funded by the National Cancer Institute; RTOG 94-08 ClinicalTrials.gov number, NCT00002597.)

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Supported by grants (U10 CA21661, to the Radiation Therapy Oncology Group [RTOG]; U10 CA37422, to the Community Clinical Oncology Program; and U10 CA32115, to the RTOG Statistical Center) from the National Cancer Institute.

Dr. Chetner reports receiving lecture fees from and serving on the advisory boards of Amgen, Ferring, GlaxoSmithKline, and Eli Lilly and receiving fees for the development of educational presentations from Amgen and GlaxoSmithKline; and Dr. Sandler, consulting fees from Calypso Medical and Varian.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

No other potential conflict of interest relevant to this article was reported.

Source Information

From Radiological Associates of Sacramento, Sacramento, CA (C.U.J., M.H.L.); the Radiation Therapy Oncology Group Statistical Center (D.H.) and the School of Nursing, University of Pennsylvania, (D.W.B.) — both in Philadelphia; the Department of Radiation Oncology, Cross Cancer Institute, Edmonton (D.G.M.); the Division of Urology, Department of Surgery, University of Alberta, Edmonton (M.P.C.); and the Department of Radiation Oncology, Tom Baker Cancer Centre, Calgary (S.M.H.) — all in Alberta, Canada; the Department of Pathology and Laboratory Medicine (M.B.A.) and the Department of Radiation Oncology, Samuel Oschin Comprehensive Cancer Institute, Cedars–Sinai Medical Center, Los Angeles (H.M.S.); the Department of Radiation Oncology, State University of New York Health Science Center at Brooklyn, Brooklyn (M.R.); the Department of Radiation Oncology, McGill University, Montreal (L.S.); and the Department of Radiation Oncology, Massachusetts General Hospital, Boston (W.U.S.).

Address reprint requests to Dr. Jones at Radiological Associates of Sacramento, 1500 Expo Pkwy., Sacramento, CA 95816, or at jonesc@radiological.com.

 


[1]   * Those made quite sick from the ADT was equaled to their claim of lives saved.  But since raw data is not available for NJM, the reasonable assumption is that the side effects were both greater and quite serious, and the survival difference is less than claimed--see article comparing raw data to published results at …….

 

Prostate cancer is often slowed by the removal of the testes (the principal source of testosterone) or by the use of a drug that blocks testosterone.  However, this is overdone for most prostate cancers are indolent.  There is however an uncertain as to whether a particular prostate cancer is indolent, and for who long it will remain that way.  However, given the effects upon the quality of life, this intervention occurs too often.  Below is an article which questions the common practice.

 

 

Prostate-Cancer Treatment Questioned

By KEITH J. WINSTEIN
March 20, 2008; Page D5

 

Prostate-Cancer Treatment Questioned

By KEITH J. WINSTEIN
March 20, 2008; Page D5

Hormone therapy, an aggressive treatment for prostate cancer, may be overused, a new study suggests.  Treatment used to reduce the size of the prostate has been shown to improve survival in advanced cancers, but doctors have increasingly been giving hormone therapy in less-severe cases.

The study, published in this week's New England Journal of Medicine, charted the quality of life for 1,201 men and their partners after the men received three kinds of prostate-cancer treatment: removal of the prostate; implantation of radioactive seeds; and radiation therapy in a laboratory. The prostate is a gland that helps make semen.  About a third of the patients who received radiation therapy or radioactive seeds also took hormones, and those patients had more problems with energy and sexual function. Doctors and patients made their own decisions about what treatments to take and weren't assigned to different groups by the study, so the study's conclusions are more suggestive than definitive.

Martin Sanda, a urologist at Beth Israel Deaconess Medical Center in Boston, who led the study, said the findings would "throw a splashful of cold water" on the practice of providing hormone therapy for less-severe cancers.  "Doctors or their patients should think twice if they're considering hormone therapy," Dr. Sanda said. "Most of the cancers that are treated nowadays are not really that aggressive."

Treating prostate cancer is a balancing act. Aggressive treatments and surgery can usually cure it -- more than 99% of patients now survive at least five years, up from 69% thirty years ago. But too much treatment can make a patient needlessly miserable.

In the U.S., about one in six men will be diagnosed with prostate cancer over their lifetimes, according to the American Cancer Society. Among men, it is the most common cancer and the No. 2 killer, behind lung cancer. This year, that will be about 186,000 diagnoses and 28,700 deaths in the U.S., the society estimates.

 

 

NEGM (New England Journal of Medicine, volume 358:1250-1261, March 20, 2008, Number 12. http://content.nejm.org/cgi/content/abstract/358/12/1250

 

Quality of Life and Satisfaction with Outcome among Prostate-Cancer Survivors

Martin G. Sanda, M.D., Rodney L. Dunn, M.S., Jeff Michalski, M.D., Howard M. Sandler, M.D., Laurel Northouse, R.N., Ph.D., Larry Hembroff, Ph.D., Xihong Lin, Ph.D., Thomas K. Greenfield, Ph.D., Mark S. Litwin, M.D., M.P.H., Christopher S. Saigal, M.D., M.P.H., Arul Mahadevan, M.D., Eric Klein, M.D., Adam Kibel, M.D., Louis L. Pisters, M.D., Deborah Kuban, M.D., Irving Kaplan, M.D., David Wood, M.D., Jay Ciezki, M.D., Nikhil Shah, D.O., and John T. Wei, M.D

ABSTRACT

Background We sought to identify determinants of health-related quality of life after primary treatment of prostate cancer and to measure the effects of such determinants on satisfaction with the outcome of treatment in patients and their spouses or partners.

Methods We prospectively measured outcomes reported by 1201 patients and 625 spouses or partners at multiple centers before and after radical prostatectomy, brachytherapy, or external-beam radiotherapy. We evaluated factors that were associated with changes in quality of life within study groups and determined the effects on satisfaction with the treatment outcome.

Results Adjuvant hormone blocking therapy was associated with worse outcomes across multiple quality-of-life domains among patients receiving brachytherapy or radiotherapy. Patients in the brachytherapy group reported having long-lasting urinary irritation, bowel and sexual symptoms, and transient problems with vitality or hormonal function. Adverse effects of prostatectomy on sexual function were mitigated by nerve-sparing procedures. After prostatectomy, urinary incontinence was observed, but urinary irritation and obstruction improved, particularly in patients with large prostates. No treatment-related deaths occurred; serious adverse events were rare. Treatment-related symptoms were exacerbated by obesity, a large prostate size, a high prostate-specific antigen score, and older age. Black patients reported lower satisfaction with the degree of overall treatment outcomes. Changes in quality of life were significantly associated with the degree of outcome satisfaction among patients and their spouses or partners.

Conclusions Each prostate-cancer treatment was associated with a distinct pattern of change in quality-of-life domains related to urinary, sexual, bowel, and hormonal function. These changes influenced satisfaction with treatment outcomes among patients and their spouses or partners.

 

There are patterns to care.  One is to over prescribe:  it is the safe things.  Doctors are not sued for giving standard treatment.  If a conditions progresses, most people will think it is because of the medication withheld.  Thus even when the treatment has a profound effect upon the quality of life, most physicians will nevertheless prescribe that drug.  One particular one is for the prevention of epileptic seizures.  Others are chemo therapy for cancers

 

Other reasons for medicating include financial gain through the need to monitor the physician, and assorted social pressures exerted by other physicians and drug salesmen.  Moreover it is quicker to write a script then explain why not.