Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Cancer
Metastatic Cancer
Treatment
Home-based, telehealth
Placebo
creatine monohydrate
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject age ≥ 18 years old.
Metastatic castration-sensitive prostate cancer patients who have not met criteriafor disease progression (per Prostate Cancer Working Group guidelines) on currentsystemic therapy
Currently treated with surgical castration or medical castration withGonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgenreceptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone,enzalutamide, apalutamide, darolutamide). Must have started the current regimen atleast 12 weeks prior to enrollment.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Not currently adhering to national physical activity guidelines for resistancetraining, as defined as participating in structured resistance training (e.g., timeset aside in your day to workout) ≥ two days per week.
Regular access to an electronic device with internet service and ability for videocalls (e.g., computer, smart phone, iPad, tablet, etc).
Access to an active MyChart account or the willingness to create an account for thepurposes of the trial.
Willingness to engage in a home-based resistance exercise program two days per week.
Willingness to take creatine monohydrate supplementation or placebo for the durationof the 52 week trial and to avoid taking additional creatine-containingsupplementation or other nutritional supplementation during the study period.
Willingness to complete and submit weekly supplementation logs to study personnelthroughout the duration of the 52-week study via email, text, in person, or verballyverified over the phone.
Willingness to complete three in-person assessment sessions (baseline, 24-, and 52-weeks).
Able to provide informed consent and willing to sign an approved consent form thatconforms to federal and institutional guidelines.
Exclusion
Exclusion Criteria:
Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2.
ECOG Performance Status ≥ 3
Study Design
Study Description
Connect with a study center
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
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