Targeted radiation therapy for high-risk prostate cancer using advanced imaging

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 effectiveness of PSMA PET/MR guided stereotactic body radiation therapy (SBRT) with simultaneous integrated boost for patients with high-intermediate and high-risk prostate cancer. The study aims to enroll 50 male participants who will receive personalized radiation treatment based on advanced imaging techniques that enhance tumor visualization and treatment precision. By utilizing real-time adaptive planning during radiation delivery, the trial seeks to improve clinical outcomes and reduce recurrence rates in aggressive prostate cancer cases. The approach combines novel imaging with innovative radiation technology to better target areas at risk of cancer recurrence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male aged 21 years or older.
* Ability to provide signed informed consent and willingness to comply with protocol requirements.
* Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows: a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, \>50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease)
* Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity.
* No evidence of metastatic disease, including pelvic lymph nodes.

Exclusion Criteria:

* Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR.
* Contraindications to PSMA IV administration
* Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate)
* Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
* Patients on or intending to take abiraterone will be excluded

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Silvia Formenti, M.D. — Weill Medical College of Cornell University
• Study coordinator: Fabiana Gregucci, M.D.
• Email: fgr4002@med.cornell.edu
• Phone: 646-962-3110

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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.