NCT06941363 Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence
| NCT ID | NCT06941363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milano Bicocca |
| Condition | Prostate Cancer (Post Prostatectomy) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2033-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-05-02 with a primary completion date of 2033-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06941363 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 90 Years, studying Prostate Cancer (Post Prostatectomy). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941363 currently recruiting?
Yes, NCT06941363 is actively recruiting participants. Contact the research team at stefano.arcangeli@unimib.it for enrollment information.
Where is the NCT06941363 trial being conducted?
This trial is being conducted at Monza, Italy.
Who is sponsoring the NCT06941363 clinical trial?
NCT06941363 is sponsored by University of Milano Bicocca. The trial plans to enroll 50 participants.
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