Resistance Training +/− Creatine for Prostate Cancer

Overseen by Adriana Coletta

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Utah

Must be taking: CYP17A1 inhibitors, GnRH agonists

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Low eGFR, Extensive bone disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if weight lifting can improve health in prostate cancer patients whose cancer has spread. Exercise strengthens muscles and helps them work better.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. However, you must be on a stable regimen of certain prostate cancer treatments for at least 12 weeks before joining the trial.

What data supports the effectiveness of the treatment Resistance Training +/− Creatine for Prostate Cancer?

Research shows that resistance exercise can improve body composition, physical function, and muscle strength in prostate cancer patients, especially those undergoing androgen deprivation therapy. Additionally, physical activity, including resistance training, may have beneficial effects on prostate cancer outcomes and overall survival. ^{1 2 3 4 5}

Is creatine supplementation and resistance training safe for prostate cancer patients?

Creatine supplementation and resistance training have been shown to be safe in various studies, including those involving older adults and clinical populations. Exercise programs, including resistance training, have been found to improve physical function and quality of life in prostate cancer patients, even those undergoing androgen deprivation therapy. ^{2 5 6 7 8}

How does the exercise intervention treatment differ from other treatments for prostate cancer?

This treatment is unique because it combines resistance training with or without creatine supplementation to improve muscle strength and physical function in prostate cancer patients undergoing androgen deprivation therapy, which is different from standard drug treatments that primarily focus on hormone levels. ^{2 7 9 10 11}

Research Team

Adriana Coletta

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

This trial is for metastatic prostate cancer patients who can read English, have internet access for video calls, and are willing to do a home-based exercise program. They must be on certain cancer treatments for at least 12 weeks before joining and get their oncologist's okay to start exercising.

Inclusion Criteria

I am willing to not take any creatine supplements if I join the resistance training group.

I've been on hormone therapy for prostate cancer for at least 12 weeks.

I am willing to take creatine and do resistance training without using other supplements for 12 weeks.

Exclusion Criteria

I haven't had chemotherapy in the last 12 weeks.

My doctor thinks my cancer spread won't stop me from joining the exercise program.

My kidney function is severely reduced.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo resistance training with or without creatine supplementation for 12 weeks

12 weeks

24 visits (in-person, twice weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Creatine Monohydrate (Other)
• Exercise Intervention (Other)

Trial Overview The study looks at whether resistance training improves body composition and health in prostate cancer patients with fatigue. It compares the effects of doing exercises alone or combined with a creatine supplement over 12 weeks.

Participant Groups

Group I: Group II (resistance training, creatine supplementation) Experimental Treatment 3 Interventions

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 II: Group I (resistance training) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., et al.[2022]

In a study of 83 prostate cancer patients undergoing 6 months of resistance exercise, high compliance (88.5%) was linked to greater improvements in trunk fat mass and appendicular lean mass, indicating that sticking to the exercise regimen can enhance body composition outcomes.

Despite varying levels of compliance, significant improvements in physical function and muscle strength were observed across the board, suggesting that resistance exercise is beneficial for all participants, even those with lower attendance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting Attendance and Resistance Exercise Compliance in Men with Localized Prostate Cancer. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

This study is a randomized, double-blind, placebo-controlled trial investigating the effects of creatine supplementation combined with resistance training on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy, with a focus on fat-free mass as the primary endpoint.

If successful, the trial could show that creatine supplementation enhances the benefits of resistance training, potentially improving body composition and quality of life for cancer patients, which would be significant for future treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. Fairman, CM., Kendall, KL., Newton, RU., et al.[2020]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

Supervised physical training significantly improves muscle strength in prostate cancer patients undergoing androgen deprivation therapy (ADT), with notable increases in chest strength (3.15 kg) and leg press strength (27.46 kg).

However, the training did not lead to significant changes in lean body mass, suggesting that while exercise can enhance strength, it may not be enough to counteract muscle loss associated with ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Physical Training Enhances Muscle Strength but Not Muscle Mass in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: A Systematic Review and Meta-Analysis. Chen, Z., Zhang, Y., Lu, C., et al.[2020]

This study aims to evaluate the effectiveness of a 16-week supervised resistance training program, with and without creatine supplementation, in patients with breast cancer, focusing on improving muscle strength and preventing sarcopenia.

Participants will be randomly assigned to either a resistance training group or a resistance training plus creatine group, allowing researchers to assess the specific impact of creatine on strength adaptations in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study): Protocol for a Randomized Controlled Trial. Martinez Aguirre-Betolaza, A., Cacicedo, J., Castañeda-Babarro, A.[2023]

A 12-week resistance training program significantly improved lean mass, reduced body fat percentage, and enhanced strength and quality of life in prostate cancer patients undergoing androgen deprivation therapy, with notable improvements in sarcopenia prevalence.

The addition of protein supplementation did not provide extra benefits for body composition changes compared to resistance training alone, and the intervention did not significantly affect metabolic syndrome or physical function outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. Dawson, JK., Dorff, TB., Todd Schroeder, E., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on physical performance and health-related quality of life in prostate cancer patients: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy: an update systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Reporting Attendance and Resistance Exercise Compliance in Men with Localized Prostate Cancer. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. [2020]

8. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Supervised Physical Training Enhances Muscle Strength but Not Muscle Mass in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: A Systematic Review and Meta-Analysis. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study): Protocol for a Randomized Controlled Trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. [2018]