High-dose single fraction 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 clinical trial evaluates the safety and efficacy of a single fraction of 24 Gy high-dose-rate radiation therapy that spares the urethra in patients with localized prostate cancer. Participants will undergo staging exams, including PSMA PET/CT scans, and if eligible, will receive treatment after fiducial implantation and imaging simulations. The study aims to assess acute and late toxicity, biochemical control, overall survival, cancer-specific survival, and quality of life through questionnaires in a total of 70 patients. The trial is designed to monitor toxicity levels closely to ensure patient safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5
* Patients over 18 years of age
* Signed informed consent
* Negative lymph nodes confirmed by imaging (PSMA PET/CT and/or pelvic MRI with and without contrast medium) where recommended by guidelines (intermediate and high risk patients, according to National Comprehensive Cancer Network (NCCN) guidelines) in the previous 3 months
* Clinical M0 (PSMA PET/CT and/or bone scan and/or pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and high risk patients, according to NCCN guidelines), in the previous 3 months
* Acceptable uroflowmetry: peak urine flow index (peak flow preferably ≥ 15 ml/s), post voiding residue (PVR) ≤50 cc. If lower, acceptable if, by carrying out 3 months of neoadjuvant hormone therapy + alpha-lytic for the reduction of prostate volume, uroflowmetry is reset to at least ≥ 12 ml/s.
* PS (ECOG) ≤2
* No previous pelvic radiotherapy
* Other conditions necessary for the correct execution of the proposed treatment (ability to fill in the questionnaires for the evaluation of the Quality of Life EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)

Exclusion Criteria:

* Serious systemic diseases
* Psychic or other disorders that may prevent the patient from signing the informed consent
* Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the oral cavity or bladder)
* Lymph node disease (N1)
* Evidence of distant metastases (M1)
* IPSS questionnaire data \> 20 points
* Uroflowmetry with maximum basal flow ≤ 11 ml/sec and/or PVR \>100 ml
* Concomitant urinary/gastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)
* Overactive bladder
* Impossibility of implantation of fiducials
* Inability or refusal to place bladder catheter for simulation CT and MR
* Inability to perform simulation MRI
* Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease
* Non-compliance with dose limits established in the treatment plan

Where it's running

• San Raffaele Scientific Institute
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Andrei Fodor, MD
• Email: fodor.andrei@hsr.it
• Phone: +390226437634

Similar studies

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

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• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

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• MRI-based microboost SBRT with de-escalated whole-gland radiation for localized prostate cancer

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  Recruiting Phase 2 Georgetown University · Washington D.C., District of Columbia · NCT07644598

• Short-term hormone therapy with PSMA PET/CT before prostate removal for high-risk localized prostate cancer

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• Comparing Lutetium-177 and Actinium-225 PSMA-targeted radiation before prostatectomy

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  Recruiting Phase 1 University of California, San Francisco · San Francisco, California · NCT07054346

• Wrapping nerves with a multi-layer perinatal tissue graft during prostate removal

  This trial will test whether wrapping the nerves with a multi-layer perinatal tissue allograft during nerve-sparing robotic prostate removal helps men with localized prostate cancer keep erectile and urinary function.

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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.