Last updated: April 2, 2024
Sponsor: University of Utah
Overall Status: Active - Recruiting
Phase
3
Condition
Metastatic Cancer
Prostate Cancer, Early, Recurrent
Prostate Cancer
Treatment
Home-based, telehealth
creatine monohydrate
Placebo
Clinical Study ID
NCT06112990
HCI168125
1R01CA281759-01
10066516
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 criteria fordisease progression (per Prostate Cancer Working Group guidelines) on current systemictherapy
- 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
Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Home-based, telehealth
Phase: 3
Study Start date:
November 09, 2023
Estimated Completion Date:
November 30, 2028
Study Description
Connect with a study center
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
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