Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

NCT03987217 | Completed Early Phase 1 DMC

• 3 other identifiers: HCI120424NCI-2019-02877P30CA042014
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Metastatic Prostate Carcinoma; Sedentary Lifestyle; Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8; Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8; Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8

Outcome Measures

Primary Outcomes (1)

• Change in lean mass

  Assessed by whole-body dual x-ray absorptiometry (DXA) scan.

  Baseline to 12 weeks post intervention

Secondary Outcomes (13)

• Change in fat mass

  Baseline to 12 weeks post intervention

• Change in fat-free mass

  Baseline to 12 weeks post intervention

• Change in percent body fat

  Baseline to 12 weeks post intervention

• Change in appendicular lean mass

  Baseline to 12 weeks post intervention

• Change in physical function

  Baseline to 12 weeks post intervention

Study Arms (2)

Group I (resistance training)

EXPERIMENTAL

Patients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.

Behavioral: Exercise Intervention; Other: Questionnaire Administration

Group II (resistance training, creatine supplementation)

EXPERIMENTAL

Patients complete POWER resistance training program sessions twice weekly over 30-60 minutes each for 12 weeks and receive creatine monohydrate supplementation given orally 4 times daily during week 1, and then QD (once per day) during weeks 2-12.

Dietary Supplement: Creatine Monohydrate; Behavioral: Exercise Intervention; Other: Questionnaire Administration

Interventions

Creatine Monohydrate DIETARY_SUPPLEMENT

Given orally

Also known as: Creatine Supplement

Group II (resistance training, creatine supplementation)

Exercise Intervention BEHAVIORAL

Complete POWER resistance training program

Group I (resistance training); Group II (resistance training, creatine supplementation)

Questionnaire Administration OTHER

Ancillary studies

Group I (resistance training); Group II (resistance training, creatine supplementation)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
• Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m\^2.
• Metastatic disease that, in the opinion of the treating oncologist, may obstruct compliant participation in the exercise program (i.e. extensive bone disease).
• 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).

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Fatigue; Prostatic Neoplasms; Sedentary Behavior

Interventions

Creatine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Adriana Coletta

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 14, 2019
• Study Start: June 17, 2019
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)