NCT06941363Recruiting
Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 15 Apr 2025
- Start date
- 2 May 2025
- Primary completion date
- May 2033
- Lead sponsor
- University of Milano Bicocca
- Diseases
- Prostate cancer
- NCT number
- NCT06941363
What you commit to
- Study type: Observational
- Planned participants: 50
- From 2 May 2025 to the primary completion date, May 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation of any kind to the prostate gland or pelvis
- Prior brachytherapy
- Patients who are on immunosuppressant medication
Other illness
- History of inflammatory colitis or other active severe comorbidities
Other
- N1 and or M1 patients
- Macroscopic local relapse at pelvic MRI.
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca) Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.