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Eligibility
for males ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator
Stacey A Kenfield

Description

Summary

This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the effects of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance exercise vs. usual care in men with metastatic castration resistant prostate cancer to determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and a prognostic score.

Details

This is a PI-initiated, randomized clinical trial of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance exercise vs. usual care among 60 men with metastatic castration resistant prostate cancer. Eligible men will be randomized with equal probability to one of the three regimens. All patients will receive a packet of print material on diet, exercise, and psycho-social support appropriately geared for men with late stage disease at the end of the trial. The aerobic exercise arm (N=20) will receive a 3 day/week supervised exercise regimen that includes high-intensity interval training and continuous vigorous intensity aerobic exercise training. The resistance exercise arm (N=20) will receive a 3 day/week resistance exercise regimen incorporating different volumes and loads. Men in the control arm (N=20) will be asked to continue their typical exercise practices for 12 weeks. Subjects will be asked to complete questionnaires, physical function and strength tests, body measurements, and collection of blood specimen at baseline and 12 weeks.

Keywords

Prostate Cancer

Eligibility

You can join if…

Open to males ages 18 years and up

  • Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic bone or node metastatic disease despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH)agonist. Castrate levels of testosterone must be maintained.
  • Patients must have PSA ≥2 ng/ml that has risen serially on at least 2 occasions, each at least one week apart
  • On ADT with a Gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT throughout the study;
  • ≥4 weeks since any major surgery and fully recovered.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Required Initial Laboratory Values:
  • Absolute neutrophil count (ANC) ≥ 1500/uL
  • Platelet count ≥ 100,000/uL
  • Creatinine ≤ 1.5 x upper limits of normal
  • Bilirubin ≤ 1.5 x upper limits of normal
  • Aspartate aminotransferase (AST) ≤ 1.5 x upper limits of normal
  • PSA ≥ 2 ng/ml
  • Serum testosterone ≤ 50 ng/dL
  • Medical clearance to undergo steep ramp test and completion of steep ramp test
  • Physician consent to participate in vigorous aerobic or resistance exercise training

You CAN'T join if...

  • Previously identified small cell neuroendocrine tumors or pure small cell carcinoma of the prostate, based on a prior biopsy of the prostate.
  • Brain metastases (brain imaging is not required)
  • Any prior chemotherapy for castrate-resistant disease
  • Poorly controlled hypertension.
  • Current congestive heart failure (New York Heart Association Class II, III or IV)
  • Recent serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI).
  • Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient
  • Serious or non-healing wound, ulcer, or bone fracture.
  • Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
  • Peripheral neuropathy ≥grade 3.
  • Men participating in vigorous aerobic exercise for 60 minutes or more per week and/or resistance exercise three or more days per week
  • Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living
  • Has difficulty climbing a flight of stairs or walking eight blocks due to physical impairment
  • Has been recommended by a doctor to only medically supervised activity
  • Has chest pain brought on by physical activity
  • Has developed chest pain in the past month
  • Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
  • Men who do not complete the baseline lifestyle and quality-of-life questionnaires and 3-days of diet diaries

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02613273
Phase
Phase 2
Lead Scientist
Stacey A Kenfield
Study Type
Interventional
Last Updated
July 1, 2016
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