Alternative radiation treatments for prostate cancer patients
Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
This study is testing new types of radiation treatment for prostate cancer to see if they are safe and effective for patients who need extra help after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 897 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT04083937 on ClinicalTrials.gov |
What this trial studies
This study investigates different radiation oncology strategies for treating prostate cancer, focusing on hypofractionated radiotherapy using both photons and protons, compared to standard normofractionated radiotherapy. It aims to determine the safety and feasibility of these approaches in patients requiring adjuvant or salvage treatment after prostatectomy. The study is prospective and randomized, allowing for a robust comparison of treatment outcomes. Participants will be monitored for their response to these radiation therapies over the course of treatment.
Who should consider this trial
Good fit: Ideal candidates include adult males with histologically confirmed prostate cancer who require prostate bed irradiation after surgery.
Not a fit: Patients with advanced prostate cancer (stage IV), those with lymphatic spread, or those who have previously undergone radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective and shorter radiation treatment options for prostate cancer patients, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown success with hypofractionated radiotherapy approaches, indicating that this method is both safe and feasible.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histology-proven prostate cancer with Gleason Score and PSA-value; * indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy; * Karnofsky-Index ≥ 70% * age ≥ 18 years Exclusion Criteria: * androgen deprivation therapy * lymphatic spread * macroscopic tumor/ R2 * stage IV (M1) * previous irradiation
Where this trial is running
Heidelberg
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Principal investigator: Juergen Debus — University Hospital Heidelberg
- Study coordinator: Juergen Debus
- Email: juergen.debus@med.uni-heidelberg.de
- Phone: 06221 56 8201
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.