Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

NCT ID: NCT03987217

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2025-03-10

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the change in lean mass with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.

SECONDARY OBJECTIVES:

I. To evaluate change in other body composition variables (i.e. fat mass, fat-free mass, percent body fat, appendicular lean mass) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.

II. To evaluate the change in health outcomes associated with body composition (i.e. physical function, fatigue, insulin regulation) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.

III. To examine associations between creatine supplementation use and changes in biomarkers linked with prostate cancer progression (prostate specific antigen [PSA] and markers of the immune system and allostatic load).

IV. To evaluate the degree of adherence to the creatine supplementation protocol.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients complete Personal Optimism with Exercise Recovery (POWER) resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I (resistance training)

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

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Complete POWER resistance training program

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Group II (resistance training, creatine supplementation)

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.

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Exercise Intervention

Intervention Type: BEHAVIORAL

Complete POWER resistance training program

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Creatine Monohydrate

Given orally

Intervention Type: DIETARY_SUPPLEMENT

Exercise Intervention

Complete POWER resistance training program

Intervention Type: BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Creatine Supplement

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adriana Coletta

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

NCI-2019-02877

Identifier Type: REGISTRY

Identifier Source: secondary_id

HCI120424

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA042014

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HCI120424

Identifier Type: -

Identifier Source: org_study_id