Actively Recruiting
Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
Led by University of Milano Bicocca · Updated on 2026-02-02
50
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility
CONDITIONS
Official Title
Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Signed informed consent before starting the study
- Diagnosed with adenocarcinoma of the prostate treated with any type of radical prostatectomy
- Detectable post-prostatectomy PSA of 0.1 to less than 2.0 ng/mL, either persistent or developing after surgery
- No evidence of lymph node (N1) or distant metastases (M1) by PSMA PET-CT within 90 days before enrollment
- Negative pelvic MRI if PSMA PET-CT shows unclear local relapse
- Androgen deprivation therapy allowed as per doctor's discretion
- ECOG performance status of 0 or 1
- Able to complete study questionnaires
You will not qualify if you...
- Presence of lymph node (N1) or distant metastases (M1)
- Macroscopic local relapse detected by pelvic MRI
- Prior radiation therapy to the prostate gland or pelvis
- Prior brachytherapy treatment
- History of inflammatory colitis or other severe active comorbidities
- Current use of immunosuppressant medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)
Monza, Italy, Italy, 20900
Actively Recruiting
Research Team
S
Stefano Arcangeli, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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