Skip to main content
Eligibility
for males ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

Randomized, phase 2 study to assess the impact of the multi-disciplinary STAND clinic on changes in key metabolic parameters, quality of life, and patient satisfaction among men receiving androgen deprivation therapy for prostate cancer. Standard-of-care therapy will consist of every 3-month visits comprised of review of medical history, toxicity assessment, and lifestyle modification counseling provided by a dietitian and exercise physiologist on an as-needed basis. Men randomized to participate in the multi-disciplinary STAND clinic will have, in addition to every 3-month visits with an individual health care provider, structured and individualized exercise and dietary counseling. A separate non-randomized patient cohort of 20 patients who are receiving concurrent chemohormonal therapy will be enrolled in parallel. The primary hypothesis of the study is that active participation in a multi-disciplinary clinic, as compared to current standard-of-care, will lead to lessened impact of androgen deprivation therapy on metabolic parameters and improved quality of life.

Official Title

A Multidisciplinary Team-Based Approach to Mitigate the Impact of Androgen Deprivation Therapy in Prostate Cancer: a Randomized Phase 2

Keywords

Prostate Cancer Cancer Supportive Therapy Androgen Deprivation Therapy Hormones Prolactin Release-Inhibiting Factors Androgens

Eligibility

You can join if…

Open to males ages 18 years and up

  • Histologic confirmation of adenocarcinoma of the prostate
  • Receiving or planning to receive ADT with LHRH agonist or antagonist
  • Expected duration of ADT at least 12 months from date of study consent
  • Concurrent antiandrogen therapy allowed but not required
  • First dose of LHRH agonist or antagonist no more than 6 months prior to date of study consent
  • Prior/concurrent radiation allowed
  • Other investigational agents in addition to LHRH agonist/antagonist are allowed (e.g.novel anti-androgens, androgen synthesis inhibitors)
  • Prior androgen deprivation therapy allowed, provided there is documented evidence of testosterone recovery to> 150 ng/dL and greater than 12 months duration between last"effective" date of ADT and date of study consent
  • ECOG performance status of 0 - 2
  • Ability to sign written informed consent
  • Willing to attend monthly clinic visits at UCSF

Randomized cohort only:

  • No prior chemotherapy within 12 months of start date of study
  • No planned chemotherapy at least 12 months from study entry

Non-randomized pilot cohort:

  • Concurrent chemotherapy (initiated within 3 months of study entry) or planned chemotherapy within 3 months of study entry

You CAN'T join if...

  • Physically unable or unwilling to participate in recommended exercise programs or travel to UCSF on a monthly basis
  • Presence of permanent pacemaker or implantable medical device (artificial joint prostheses and venous filters are allowed)

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02168062
Phase
Phase 2
Lead Scientist
Rahul Aggarwal
Study Type
Interventional
Last Updated
October 2016
I'm interested in this study!