Status:
RECRUITING
Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
Lead Sponsor:
University of Milano Bicocca
Conditions:
Prostate Cancer (Post Prostatectomy)
Eligibility:
MALE
18-90 years
Brief Summary
Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, ...
Detailed Description
Patients enrolled in this observational prospective trial undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as per clinical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2033
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06941363
Start Date
May 2 2025
End Date
May 1 2033
Last Update
October 3 2025
Active Locations (1)
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1
Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)
Monza, Italy, Italy, 20900