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A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy


Literature has shown that low dose estrogens can control hot flashes in men on androgen
deprivation but with a high risk of thromboembolic events. Soy derivatives that contain
isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a
possible safer alternative to synthetic estrogens but there has not been a similar study
performed on their effect in men on androgen deprivation therapy for prostate cancer.


Inclusion Criteria:



- Histologically proven adenocarcinoma of prostate with treatment of prostate cancer
(radical prostatectomy, radiation therapy, etc.)

- had biochemical/clinical relapse and started on antiandrogens

- have documented history of hot flashes

Exclusion Criteria:

- History of MI, DVT, CVA

- peanut allergy

- untreated hypothyroidism

- must be off other medical treatment for hot flashes for 2 weeks before enrollment in
this study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

efficacy of using isoflavones as safer alternative to synthetic estrogens

Outcome Time Frame:

16 Weeks

Safety Issue:

Yes

Principal Investigator

Jeffrey M. Holzbeierlein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

9639

NCT ID:

NCT00594620

Start Date:

August 2004

Completion Date:

April 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353