Status:
RECRUITING
POst-Prostatectomy Ablative Radiation Therapy
Lead Sponsor:
University of Milano Bicocca
Conditions:
Radiation Toxicity
Eligibility:
MALE
18-90 years
Brief Summary
The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can ...
Detailed Description
In this observational prospective trial eligible patients are those with adverse pathological features or rising PSA after radical prostatectomy proposed for receiving 31 Gy in 5 sessions each of 6.2 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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).
- Pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin
- Post-radical prostatectomy PSA of ≥ 0.1 - \< 2.0 ng/mL.
- Clinical local relapse assessed by Magnetic Resonance Imaging (MRI) of the pelvis
- ECOG performance status of 0-1
- No distant metastases at restaging (in case of biochemical failure), within 60 days prior to registration
- Patients can be on androgen deprivation therapy
- Ability to understand and willingness to sign a study-specific informed consent prior to study entry
- EXCLUSION CRITERIA
- N1 and or M1 patients
- Prior radiation of any kind to the prostate gland or pelvis
- Prior brachytherapy is not allowed
- History of inflammatory colitis or other active severe comorbidities
- Patients who are on immunosuppressant medication
Exclusion
Key Trial Info
Start Date :
April 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04831970
Start Date
April 15 2021
End Date
December 31 2026
Last Update
October 25 2022
Active Locations (2)
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1
Radiation Oncology, Humanitas Cancer Center (Humanitas University)
Rozzano, MI, Italy, 20089
2
Radiation Oncology, ASST Monza (University of Milan Bicocca)
Monza, Italy, 20900