Salvage radiation therapy for prostate cancer recurrence

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 focuses on patients with prostate cancer who experience biochemical recurrence after radical prostatectomy. Participants will receive a single session of stereotactic body radiotherapy (SBRT) targeting the prostate bed, utilizing advanced image-guided techniques to ensure precision and minimize damage to surrounding tissues. The study aims to evaluate the oncological outcomes and toxicity profiles associated with this treatment approach. Patients will be monitored for toxicity and PSA levels over a follow-up period of up to 24 months.

Why it matters

Who can join: the full rules

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

Where it's running

• Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)
  Monza, Italy, Italy Recruiting

Study contacts

• Study coordinator: Stefano Arcangeli, MD
• Email: stefano.arcangeli@unimib.it
• Phone: +39 0392333663

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Epidemiology, diagnosis, and treatment patterns of prostate cancer in Algeria

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• Shorter Salvage Radiotherapy after Prostate Surgery for Recurrent Prostate Cancer

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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.