80 Participants Needed

Exercise + Radiation Therapy for Prostate Cancer

Recruiting at 2 trial locations
NZ
JC
NG
Overseen ByNicholas G Zaorsky, MD, MS
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study is being done to determine if patients receiving personalized exercise therapy (versus those who do not receive personalized exercise therapy) have improved quality of life and physical functioning after completing their radiation therapy. Second, the study is being done to find if the quality of life changes during therapy correlate with measurements of inflammation in the blood. Third, the study is being done to see if adding exercise therapy to radiation therapy will improve survival.

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.

What data supports the effectiveness of the treatment Exercise + Radiation Therapy for Prostate Cancer?

Research shows that combining external beam radiation therapy with brachytherapy (a type of internal radiation) can reduce cancer recurrence in prostate cancer patients. This suggests that the radiation therapy component of the treatment may be effective in managing prostate cancer.12345

Is exercise combined with radiation therapy for prostate cancer safe?

Radiation therapy for prostate cancer, including external beam radiation and brachytherapy, has been studied for safety. Common side effects include issues with the urinary and digestive systems, but these are generally not severe. Exercise therapy is generally safe and can improve overall health, though specific safety data for its combination with radiation therapy is limited.678910

How does the Exercise + Radiation Therapy treatment for prostate cancer differ from other treatments?

This treatment is unique because it combines radiation therapy with exercise to help reduce fatigue and improve quality of life in prostate cancer patients. Exercise during radiation therapy has been shown to lessen treatment-related side effects, such as fatigue and rectal toxicity, making it a novel approach compared to standard radiation therapy alone.1112131415

Research Team

NZ

Nicholas Zaorsky, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

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.
See 5 more

Exclusion Criteria

I have had a heart attack or heart surgery in the last 6 months.
I am a man aged 18 or older.
I have experienced fainting spells.
See 15 more

Timeline

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

Treatment Details

Interventions

  • Exercise therapy
  • Radiation therapy
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Radiation Therapy + Exercise TherapyExperimental Treatment1 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 TherapyActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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.
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 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.
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 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.
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]

References

Brachytherapy versus external beam radiotherapy boost for prostate cancer: Systematic review with meta-analysis of randomized trials. [2022]
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. [2022]
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. [2018]
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. [2021]
Dose-Escalated Irradiation and Overall Survival in Men With Nonmetastatic Prostate Cancer. [2022]
[Intraoperative radiotherapy combined with external beam radiation for prostate cancer without metastasis]. [2011]
Radiation therapy for prostate cancer. [2013]
Assessing adverse events of postprostatectomy radiation therapy for prostate cancer: evaluation of outcomes in the Regione Emilia-Romagna, Italy. [2015]
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. [2018]
Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. [2022]
11.United Statespubmed.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. [2020]
Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. [2021]
13.United Statespubmed.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. [2021]
[The role of exercise in prostate cancer prevention and treatment]. [2019]
The effect of aerobic exercise on treatment-related acute toxicity in men receiving radical external beam radiotherapy for localised prostate cancer. [2010]