Actively Recruiting
POst-Prostatectomy Ablative Radiation Therapy
Led by University of Milano Bicocca · Updated on 2022-10-25
30
Participants Needed
2
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (\< 90 days from the end of treatment) and late (\> 90 days) setting.
CONDITIONS
Official Title
POst-Prostatectomy Ablative Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adenocarcinoma of the prostate treated with radical prostatectomy (any type allowed)
- Pathologic stage T3N0/Nx or T2N0/Nx disease, with or without positive surgical margins
- Post-prostatectomy PSA between 0.1 and less than 2.0 ng/mL
- Clinical local relapse confirmed by pelvic MRI
- ECOG performance status of 0 or 1
- No distant metastases within 60 days before enrollment
- Patients may be receiving androgen deprivation therapy
- Ability and willingness to provide informed consent
You will not qualify if you...
- Presence of N1 lymph node or M1 distant metastases
- Prior radiation therapy to prostate gland or pelvis
- Prior brachytherapy treatment
- History of inflammatory colitis or other active severe comorbidities
- Use of immunosuppressant medications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Radiation Oncology, Humanitas Cancer Center (Humanitas University)
Rozzano, MI, Italy, 20089
Active, Not Recruiting
2
Radiation Oncology, ASST Monza (University of Milan Bicocca)
Monza, 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
0
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