Post-surgery radiation therapy for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational trial evaluates the effects of hypofractionated image-guided radiotherapy on patients who have undergone radical prostatectomy for prostate cancer. Patients with adverse pathological features or rising PSA levels will receive targeted radiation therapy to the prostatic bed, with treatment delivered in five sessions over one week. The study aims to assess treatment-related toxicity and quality of life outcomes, using validated questionnaires and follow-up assessments over several years. The trial will also analyze biochemical relapse-free survival rates among participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Radiation Oncology, ASST Monza (University of Milan Bicocca)
  Monza, Italy Recruiting
• Radiation Oncology, Humanitas Cancer Center (Humanitas University)
  Rozzano, Mi, Italy Active not recruiting

Study contacts

• Principal investigator: Stefano Arcangeli, MD — University of Milan Bicocca
• Study coordinator: Stefano Arcangeli, MD
• Email: stefano.arcangeli@unimib.it
• Phone: +39-0392333663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.