Post-surgery radiation therapy for prostate cancer
POst-Prostatectomy Ablative Radiation Therapy
This study tests if a new type of focused radiation therapy given after prostate surgery can help prevent cancer from coming back while keeping side effects and quality of life in check for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | University of Milano Bicocca Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Rozzano, MI and 1 other locations) |
| Trial ID | NCT04831970 on ClinicalTrials.gov |
What this trial studies
This observational trial evaluates the effects of hypofractionated image-guided radiotherapy on patients who have undergone radical prostatectomy for prostate cancer. Patients with adverse pathological features or rising PSA levels will receive targeted radiation therapy to the prostatic bed, with treatment delivered in five sessions over one week. The study aims to assess treatment-related toxicity and quality of life outcomes, using validated questionnaires and follow-up assessments over several years. The trial will also analyze biochemical relapse-free survival rates among participants.
Who should consider this trial
Good fit: Ideal candidates include men with prostate adenocarcinoma who have undergone radical prostatectomy and have specific pathological features or rising PSA levels.
Not a fit: Patients with distant metastases or prior radiation treatment to the prostate or pelvis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce radiation toxicity while maintaining effective treatment for prostate cancer patients post-surgery.
How similar studies have performed: Previous studies have shown promise with hypofractionated radiotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy). * Pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin * Post-radical prostatectomy PSA of ≥ 0.1 - \< 2.0 ng/mL. * Clinical local relapse assessed by Magnetic Resonance Imaging (MRI) of the pelvis * ECOG performance status of 0-1 * No distant metastases at restaging (in case of biochemical failure), within 60 days prior to registration * Patients can be on androgen deprivation therapy * Ability to understand and willingness to sign a study-specific informed consent prior to study entry EXCLUSION CRITERIA * N1 and or M1 patients * Prior radiation of any kind to the prostate gland or pelvis * Prior brachytherapy is not allowed * History of inflammatory colitis or other active severe comorbidities * Patients who are on immunosuppressant medication
Where this trial is running
Rozzano, MI and 1 other locations
- Radiation Oncology, Humanitas Cancer Center (Humanitas University) — Rozzano, Mi, Italy (Active_not_recruiting)
- Radiation Oncology, ASST Monza (University of Milan Bicocca) — Monza, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Arcangeli, MD — University of Milan Bicocca
- Study coordinator: Stefano Arcangeli, MD
- Email: stefano.arcangeli@unimib.it
- Phone: +39-0392333663
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.