NCT03987217CompletedEarly phase 1
Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients
Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 14 May 2025
Brief summary (registry, in English)
This trial studies how well resistance training with or without creatine monohydrate supplement works in improving body composition and health outcomes in patients with prostate cancer that has spread to other places in the body. Resistance training, with or without creatine monohydrate supplement, may help to improve feelings of tiredness and overall physical function in patients with prostate cancer.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 3 Jun 2019
- Start date
- 17 Jun 2019
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- University of Utah
- Diseases
- Prostate cancer
- NCT number
- NCT03987217
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 73
- From 17 Jun 2019 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- Current or planned treatment with radiation therapy. \*Subjects who may later require radiation therapy for their health and wellbeing during the course of the trial may be allowed to continue on trial, pending consultation with the PI, treating oncologist, and medical monitor (and DSMC as applicable).
Other illness
- Metastatic disease that, in the opinion of the treating oncologist, may obstruct compliant participation in the exercise program (i.e. extensive bone disease).
Lab values
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m\^2.
Who the study is looking for
- Metastatic prostate cancer patients who have not met criteria for disease progression on ongoing systemic therapy.
- Currently treated with CYP17A1 inhibitors, surgical castration or medical castration with GnRH (gonadotropin-releasing hormone) agonists/antagonists, or androgen receptor blockers. Must have started the current regimen at least 12 weeks prior to enrollment.
- Confirmation by the patient's treating oncologist that the patient is able to start the exercise program.
- Regular access to an electronic device with internet service and ability for video calls (i.e. computer, smart phone, ipad, tablet, etc).
- Access to an active MyChart account or the willingness to create an account for the purposes of the trial.
- Must be able to read and understand English.
- Willingness to engage in a home-based resistance exercise program two days per week.
- If randomized to the creatine + resistance training group, willingness to take creatine monohydrate supplementation for the duration of the 12 week trial and avoid taking additional creatine-containing supplementation or other supplementation during the study period.
- If randomized to the resistance training group without creatine supplementation, willingness to avoid taking creatine monohydrate supplementation or additional creatine-containing supplementation or other supplementation during the study period.
- For participants randomized to the creatine arm willingness to complete and submit Weekly Creatine Supplementation logs to study personnel via email, fax, or in person.
- Willingness to complete two assessment sessions (baseline and end-of-study).
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.