Salvage radiation therapy for prostate cancer recurrence
Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
This study is testing if a precise type of radiation therapy can help men with prostate cancer who have had surgery but are seeing signs of cancer return.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | University of Milano Bicocca Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Monza, Italy) |
| Trial ID | NCT06941363 on ClinicalTrials.gov |
What this trial studies
This observational trial focuses on patients with prostate cancer who experience biochemical recurrence after radical prostatectomy. Participants will receive a single session of stereotactic body radiotherapy (SBRT) targeting the prostate bed, utilizing advanced image-guided techniques to ensure precision and minimize damage to surrounding tissues. The study aims to evaluate the oncological outcomes and toxicity profiles associated with this treatment approach. Patients will be monitored for toxicity and PSA levels over a follow-up period of up to 24 months.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with detectable PSA levels post-prostatectomy and no evidence of metastatic disease.
Not a fit: Patients with advanced metastatic prostate cancer or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less toxic option for managing prostate cancer recurrence.
How similar studies have performed: Other studies utilizing similar SBRT approaches have shown promising results, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects of male sex ≥ 18 years of age. * Subjects have freely signed the pertinent informed consent before the beginning of the study * 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) * Detectable post-prostatectomy PSA of ≥ 0.1 - \< 2.0 ng/mL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable) * No evidence of N1 and/or M1 disease assessed by PSMA PET-CT within 90 days prior to registration * Negative Magnetic Resonance Imaging (MRI) of the pelvis in case of equivocal evidence of local relapse on PSMA PET-CT * Androgen deprivation therapy (ADT) allowed as per physician's discretion * ECOG performance status of 0-1 * Ability to complete the questionnaires Exclusion Criteria: * N1 and or M1 patients * Macroscopic local relapse at pelvic MRI. * Prior radiation of any kind to the prostate gland or pelvis * Prior brachytherapy * History of inflammatory colitis or other active severe comorbidities * Patients who are on immunosuppressant medication
Where this trial is running
Monza, Italy
- Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca) — Monza, Italy, Italy (Recruiting)
Study contacts
- 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.