Training program for men with prostate cancer on hormone therapy
ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.
NA · The Swedish School of Sport and Health Sciences · NCT06449664
This study is testing a new exercise program for men with prostate cancer on hormone therapy to see if it helps reduce side effects and improve their health compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Male |
| Sponsor | The Swedish School of Sport and Health Sciences (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06449664 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new training concept designed for men undergoing androgen deprivation therapy (ADT) for prostate cancer. Participants will engage in a structured exercise regimen twice a week for 12 weeks, focusing on high-intensity resistance and aerobic training. The study aims to assess the feasibility, safety, and effectiveness of this training in mitigating the side effects associated with ADT compared to usual care. Participants will undergo assessments at baseline, 6 weeks, and 12 weeks to measure various health outcomes.
Who should consider this trial
Good fit: Ideal candidates are men with localized or locally advanced prostate cancer who are scheduled to undergo radiotherapy in combination with ADT for at least six months.
Not a fit: Patients with very high-risk localized prostate cancer or those not receiving ADT may not benefit from this training program.
Why it matters
Potential benefit: If successful, this training program could significantly reduce the side effects of hormone therapy in prostate cancer patients, improving their quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in cancer patients, suggesting potential success for this novel training approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. signed informed consent 2. histologically confirmed localised or locally advanced prostate cancer 3. planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis. Exclusion Criteria: 1. very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone 2. localized prostate cancer planned for radiotherapy without ADT 3. on-going or previously treated with ADT or other hormonal treatments 4. have any contraindications to physical testing/exercise as per the ACSM guidelines 5. unable to comply with study procedures
Where this trial is running
Stockholm
- Swedish School of Sport and Health Sciences — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Niklas Psilander, PhD
- Email: niklas.psilander@gih.se
- Phone: +46 8 120 538 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Androgen deprivation therapy, Flywheel training, High intensity training, Resistance training, Aerobic training