Exercise + Radiation Therapy for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Nicholas G Zaorsky, MD, MS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Heart failure, Coronary syndromes, Arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding personalized exercise therapy to standard radiation therapy can improve the quality of life and physical health for prostate cancer patients. Researchers seek to understand if these improvements correlate with changes in blood inflammation levels and if the combination can extend patients' lives. The trial suits men with prostate cancer experiencing lymph node involvement or metastasis, who are not already engaging in more than 90 minutes of exercise weekly. Participants will either receive exercise guidance alongside radiation or continue their usual radiation care. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows for prior or current use of hormone therapy and chemotherapy agents, so you may not need to stop these treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exercise is generally safe for people with prostate cancer. Studies indicate that exercise can improve quality of life and reduce fatigue during cancer treatment. One study found that regular exercise can lower the risk of dying from prostate cancer.

Another study suggested that exercise can be safely included in treatment plans, even for those with advanced prostate cancer. This suggests exercise might complement other treatments like radiation therapy.

Overall, evidence suggests that exercise is well-tolerated and beneficial for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining exercise with radiation therapy for prostate cancer because it could enhance the effectiveness of standard treatment. While radiation therapy is a common approach to target cancer cells, adding a personalized exercise regimen may boost patients' physical strength and improve their overall well-being during treatment. This combination could potentially lead to better outcomes, such as improved recovery rates and reduced side effects, which is why it is generating interest in the medical community.

What evidence suggests that exercise therapy combined with radiation therapy could be effective for prostate cancer?

Research has shown that exercise benefits prostate cancer patients. Studies have found that exercise not only enhances quality of life but also reduces cancer severity and slows tumor growth. Evidence suggests that supervised exercise can significantly improve disease-related quality of life. Additionally, exercise might help lower prostate-specific antigen (PSA) levels, which track prostate cancer. In some cases, exercise also improved erectile function in patients. In this trial, one group will receive both exercise therapy and standard radiation therapy, potentially offering several benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

Nicholas Zaorsky, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men over 18 with metastatic prostate cancer undergoing their first round of palliative radiation therapy. They must have had hormone therapy, be in a stable condition (ECOG ≤3), and speak English. Exclusions include severe heart conditions, respiratory failure, high fracture risk, heavy current exercisers (>90 min/week), or those treated outside the specified hospitals.

Inclusion Criteria

Fluent in written and spoken English

I am scheduled for radiation therapy at University Hospitals in Cleveland or Lake Health Center.

I am receiving a specific radiation therapy dose or SBRT.

Exclusion Criteria

I have had a heart attack or heart surgery in the last 6 months.

I have experienced fainting spells.

I am a man aged 18 or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive standard of care radiation treatment, with or without exercise therapy

5 weeks

Daily visits for radiation treatment

Exercise Therapy

Participants in the experimental group receive personalized exercise therapy alongside radiation treatment

5 weeks

1-7 exercise sessions per week, depending on tolerance

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weekly follow-up calls for 4 weeks

4 weeks

Weekly phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Exercise therapy
• Radiation therapy

Trial Overview

The EXERT study tests if personalized exercise therapy during radiation treatment improves life quality and physical function in metastatic prostate cancer patients. It also examines whether exercise affects survival rates and correlates with inflammation markers in blood.

How Is the Trial Designed?

Group I: Radiation Therapy + Exercise Therapy Experimental Treatment 1 Intervention

This group will receive exercise intervention in addition to their standard of care radiation treatment. At the baseline visit, they will meet with the certified exercise trainer (CET) and will be provided with a personalized exercise prescription and log to record what they do in between daily radiation treatment visits. The participant will also undergo an in-person exercise session prior to radiation therapy, which will take place either on the same day that the physical function tests are preformed or on a separate day. Participants will exercise between 1 and 7 times/week depending on the patient's tolerance to the exercise prescription. The CET will meet with the participant at every radiation treatment visit for an exercise counseling check-in. After five radiation treatments, the CET will follow-up with the participants via phone call once per week for 4 weeks during the follow-up period.

Group II: Radiation Therapy Active Control 1 Intervention

The observational group will continue with their usual standard of care of radiation therapy. The study team will provide patients with an educational pamphlet at the end of their baseline visit. They will also be provided with a self-directed exercise program framework. Additionally, the participant's medical record will be reviewed for serious adverse events during their time on study. Baseline and final measurements will be obtained.

Radiation therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiotherapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Skin cancer

Approved in United States as Radiation therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Skin cancer
• Cervical cancer
• Uterine cancer

Approved in Canada as Radiotherapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Skin cancer

Approved in Japan as Radiation therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Skin cancer
• Esophageal cancer

Approved in China as Radiotherapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Skin cancer
• Nasopharyngeal cancer

Approved in Switzerland as Radiation therapy for:

• Breast cancer
• Lung cancer
• Colorectal cancer
• Prostate cancer
• Brain tumors
• Skin cancer

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

A systematic review of five randomized controlled trials involving 392 participants found that exercise significantly reduces fatigue in men undergoing radiation therapy for prostate cancer, with a standardized mean difference of -1.03.

While exercise improved fatigue levels, it did not show a significant effect on quality of life, likely due to variability in the studies included in the analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Exercise during Radiation Therapy for Prostate Cancer on Fatigue and Quality of Life: A Systematic Review and Meta-analysis. Horgan, S., O'Donovan, A.[2020]

In a study of 72 prostate cancer patients undergoing radiation therapy, both high-intensity interval training (HIIT) and resistance training (RES) significantly reduced cancer-treatment-related fatigue compared to usual care, indicating their efficacy in managing side effects of treatment.

Both exercise modalities were found to be safe, with no adverse events reported, and they improved functional exercise capacity, demonstrating that structured exercise can be beneficial during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Piraux, E., Caty, G., Renard, L., et al.[2021]

Regular physical activity is beneficial for cancer patients, including those with prostate cancer, as it helps improve function and quality of life during treatment and rehabilitation.

Exercise can mitigate the side effects of cancer and its treatments, such as hormonal therapy, by preventing declines in fitness, strength, and mobility, which are often exacerbated by inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of exercise in prostate cancer prevention and treatment]. Biró, K., Géczi, L.[2019]

Radiation therapy, including brachytherapy and external beam radiotherapy, is an effective treatment option for newly diagnosed prostate cancer, as well as for salvage treatment and palliative care in advanced cases.

The study discusses the indications, results, and potential complications of using these radiation therapies alone or in combination with other treatments like androgen deprivation, highlighting their versatility in managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy for prostate cancer. Koontz, BF., Lee, WR.[2013]

Intraoperative radiotherapy combined with external beam radiation was found to be an effective treatment for non-metastatic prostate cancer, with 5-year survival rates of 92.3% for stage B and 87.2% for stage C patients based on a follow-up of 15-99 months.

While some patients experienced adverse effects like cystitis and proctitis, these symptoms were not severe, indicating that the treatment is relatively safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraoperative radiotherapy combined with external beam radiation for prostate cancer without metastasis]. Higashi, Y., Hyochi, N., Tari, K.[2011]

In a study of 9,876 men who underwent radical prostatectomy, those who received postprostatectomy radiation therapy experienced significantly higher rates of gastrointestinal (1.81 times more likely) and urinary nonincontinence adverse events (1.83 times more likely) compared to those who did not receive radiation therapy.

The timing of radiation therapy after prostatectomy did not affect the risk of these adverse events, challenging the belief that delaying radiation therapy reduces the likelihood of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing adverse events of postprostatectomy radiation therapy for prostate cancer: evaluation of outcomes in the Regione Emilia-Romagna, Italy. Showalter, TN., Hegarty, SE., Rabinowitz, C., et al.[2015]

In a study of 65 patients undergoing external beam radiotherapy, those who engaged in aerobic exercise (walking for 30 minutes at least three times a week) experienced significantly less severe acute rectal toxicity compared to those who received standard advice (P=0.004).

There was no significant difference in bladder toxicity between the exercise and control groups (P=0.123), suggesting that exercise may specifically help mitigate rectal side effects during prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of aerobic exercise on treatment-related acute toxicity in men receiving radical external beam radiotherapy for localised prostate cancer. Kapur, G., Windsor, PM., McCowan, C.[2010]

In a study of 129 patients with localized prostate cancer treated with a combination of external beam radiation and high dose rate (HDR) brachytherapy, the long-term outcomes showed a 10-year overall survival rate of 76% and a low rate of severe treatment-related adverse events (5% for grade 3 gastrointestinal and genitourinary issues).

The treatment demonstrated effective disease control, with only 23% experiencing biochemical failure and a 10-year disease-specific mortality rate of 6%, indicating that HDR brachytherapy is a safe and effective option for managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate. Hsu, IC., Rodgers, JP., Shinohara, K., et al.[2022]

In a Phase II trial involving 138 patients with localized prostate cancer, the combination of external-beam radiation therapy and low-dose-rate permanent brachytherapy showed an 8-year biochemical control rate of 82% to 79%, indicating durable effectiveness in managing the disease.

However, the study reported a significant late toxicity rate, with 15% of patients experiencing severe genitourinary or gastrointestinal side effects, and 42% reporting grade 3 impotence, suggesting a need for improved strategies to minimize damage to healthy tissues during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. Lawton, CA., Yan, Y., Lee, WR., et al.[2018]

A structured multicomponent exercise program significantly helped maintain physical functioning and reduce fatigue in prostate cancer patients undergoing androgen deprivation therapy and radiation, compared to a usual care group.

Patients who participated in the exercise program reported lower levels of clinically important pain after 6 months, suggesting that exercise can mitigate some adverse effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Exercise Adjunct to Radiation and Androgen Deprivation Therapy on Patient-Reported Treatment Toxicity in Men With Prostate Cancer: A Secondary Analysis of 2 Randomized Controlled Trials. Schumacher, O., Galvão, DA., Taaffe, DR., et al.[2021]

Brachytherapy (BT) boost significantly improves 5-year biochemical-progression-free survival compared to external beam radiotherapy (EBRT) boost for intermediate and high-risk prostate cancer, with a hazard ratio of 0.49, indicating a strong benefit.

There was no significant difference in overall survival or severe late toxicities between the two treatment methods, suggesting that while BT boost is effective, the potential for increased late toxicity should be monitored closely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachytherapy versus external beam radiotherapy boost for prostate cancer: Systematic review with meta-analysis of randomized trials. Kee, DLC., Gal, J., Falk, AT., et al.[2022]

In a study of 46,325 men with high-risk prostate cancer, androgen deprivation therapy (ADT) improved overall survival for those receiving external beam radiation therapy (EBRT) alone, but not for those receiving combined EBRT and brachytherapy.

The findings suggest that while ADT is beneficial with EBRT, it may not enhance survival in patients treated with both EBRT and brachytherapy, highlighting the need for further research to evaluate the risks and benefits of ADT in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of Apparent Survival Benefit With Use of Androgen Deprivation Therapy in Patients With High-risk Prostate Cancer Receiving Combined External Beam Radiation Therapy and Brachytherapy. Yang, DD., Muralidhar, V., Mahal, BA., et al.[2018]

In a study of 54,642 prostate cancer patients, low-dose-rate brachytherapy boost (LDR-BB) was associated with significantly higher gastrointestinal (GI) toxicity (32.3%) compared to high-dose-rate brachytherapy boost (HDR-BB) (16.7%) and external beam radiation therapy (EBRT) monotherapy (18.7%).

High-dose-rate brachytherapy boost (HDR-BB) resulted in lower incidences of skeletal-related events (2.4%) and prostate cancer-specific mortality (2.7%) compared to EBRT monotherapy (2.8% and 3.5%, respectively), indicating HDR-BB may offer better long-term outcomes in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of High-Dose-Rate and Low-Dose-Rate Brachytherapy Boost on Toxicity, Functional and Cancer Outcomes in Patients Receiving External Beam Radiation Therapy for Prostate Cancer: A National Population-Based Study. Parry, MG., Nossiter, J., Sujenthiran, A., et al.[2021]

In a study of over 42,000 men with nonmetastatic prostate cancer, dose-escalated external-beam radiation therapy (EBRT) significantly improved overall survival for those with intermediate-risk and high-risk prostate cancer, but not for low-risk patients.

For every 2 Gy increase in radiation dose, there was a notable reduction in the risk of death by 7.8% for intermediate-risk and 6.3% for high-risk patients, highlighting the potential benefits of higher radiation doses in more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Escalated Irradiation and Overall Survival in Men With Nonmetastatic Prostate Cancer. Kalbasi, A., Li, J., Berman, A., et al.[2022]

Men with prostate cancer who underwent radiotherapy (RT) had a significantly higher risk of serious adverse effects compared to controls, with a relative risk (RR) of 2.64, while those who had radical prostatectomy (RP) had an RR of 2.05, indicating increased long-term risks associated with both treatments.

Specifically, the risk of surgical procedures for urinary incontinence was much higher after RP (RR 23.64), while RT was associated with higher risks for other lower urinary tract and gastrointestinal procedures, showing that both treatment options carry distinct long-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. Fridriksson, JÖ., Folkvaljon, Y., Nilsson, P., et al.[2022]

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