What is the mechanism of action of this treatment?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, radiation therapy, and surgery. ADT works by reducing levels of androgens, which prostate cancer cells rely on for growth. Chemotherapy targets rapidly dividing cells, including cancer cells, to inhibit their proliferation. Radiation therapy uses high-energy rays to destroy cancer cells, while surgery involves the physical removal of the prostate gland. These treatments are crucial as they directly target cancer cells, aiming to reduce tumor size, prevent metastasis, and improve survival rates. In the context of resistance training and creatine monohydrate supplementation, these interventions can help mitigate treatment-related side effects such as muscle wasting and fatigue, thereby improving overall physical function and quality of life for prostate cancer patients.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), can lead to side effects including hot flashes, reduced libido, fatigue, and osteoporosis. Chemotherapy may cause nausea, hair loss, and increased risk of infections. Radiation therapy can result in urinary and bowel issues, as well as erectile dysfunction. Creatine monohydrate, often used to enhance muscle mass and exercise performance, is generally well-tolerated but may cause gastrointestinal discomfort and muscle cramping in some individuals. Resistance training is beneficial for improving muscle strength and physical function, with minimal side effects when performed correctly.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer have primarily focused on hormone therapies, chemotherapy, and newer targeted therapies. Androgen deprivation therapy (ADT) is a cornerstone treatment, often combined with drugs like enzalutamide and abiraterone, which inhibit androgen receptor signaling. Chemotherapy agents such as docetaxel are also approved for advanced stages. While resistance training and creatine monohydrate are not FDA-approved treatments, they are being studied for their potential to improve muscle strength and physical function in prostate cancer patients, particularly those undergoing other forms of cancer treatment.

What other types of research exist?

Promising alternatives include: 1) Eicosapentaenoic acid (EPA) supplementation, which has shown benefits in preserving lean body mass and improving clinical outcomes in cancer patients. 2) Multimodal interventions combining nutritional support, physical activity, and pharmacological agents like megestrol acetate or thalidomide, which have demonstrated efficacy in managing cancer cachexia and improving physical function. 3) Aerobic exercise programs tailored to cancer survivors, which can enhance cardiovascular health and overall physical endurance.

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Other

Resistance Training +/− Creatine for Prostate Cancer

Phase < 1

Recruiting

Led By Adriana Coletta

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Metastatic prostate cancer patients who have not met criteria for disease progression on ongoing systemic therapy

Must not have

Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment

Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m^2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks post intervention

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include muscle cramps or digestive issues from creatine monohydrate, as well as general risks associated with resistance training like muscle soreness or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My prostate cancer has spread, but it hasn't gotten worse on my current treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in lean mass

Secondary study objectives

Change in appendicular lean mass

Change in fat mass

Change in fat-free mass

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (resistance training, creatine supplementation)Experimental Treatment3 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 Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

Creatine Monohydrate

2009

Completed Phase 2

~270

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, radiation therapy, and surgery. ADT works by reducing levels of androgens, which prostate cancer cells rely on for growth. Chemotherapy targets rapidly dividing cells, including cancer cells, to inhibit their proliferation. Radiation therapy uses high-energy rays to destroy cancer cells, while surgery involves the physical removal of the prostate gland. These treatments are crucial as they directly target cancer cells, aiming to reduce tumor size, prevent metastasis, and improve survival rates. In the context of resistance training and creatine monohydrate supplementation, these interventions can help mitigate treatment-related side effects such as muscle wasting and fatigue, thereby improving overall physical function and quality of life for prostate cancer patients.

Effects of creatine supplementation and exercise training on fitness in men 55-75 yr old.