POst-Prostatectomy Ablative Radiation Therapy

Recruiting now

Conditions studied: Radiation Toxicity

In brief

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.

Key facts

Study ID

NCT04831970

Run by

University of Milano Bicocca

People needed

30

Starts

2021-04-15

Expected to finish

2026-12-31

Last updated by the study team

2022-10-25

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Radiation Oncology, ASST Monza (University of Milan Bicocca) — Monza, Italy (enrolling)
• Radiation Oncology, Humanitas Cancer Center (Humanitas University) — Rozzano, MI, Italy

Full record on ClinicalTrials.gov

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