Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer

Launched by MEDICAL UNIVERSITY OF BIALYSTOK · Oct 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging technique called PET/MR using a radiotracer named 68Ga-PSMA-11 to help doctors better plan treatment for men with prostate cancer. The goal is to see how effective this method is in finding cancer in patients who are at high risk or have already been treated but are experiencing a return of the disease. The study aims to gather information that may help doctors make more personalized treatment decisions.

To participate, men aged 18 and older must have a confirmed diagnosis of prostate cancer that is medium to high risk, or they must be experiencing a recurrence of the disease after treatment. Participants need to have had certain tests done recently and must be able to safely undergo the imaging procedure. Those who join the trial will receive the PET/MR scans, and their results could provide valuable insights that might change their treatment plan. It's important to note that patients with certain medical conditions or those currently involved in other clinical trials may not be eligible to participate.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned
• • Prostate adenocarcinoma confirmed by biopsy and histopathological examination
• • Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score\> 7 or cT2c or PSA\> 20 ng / ml) risk according to ISUP
• • Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance\> 60 mL / min
• • Age ≥18 years
• • Signing informed consent to participate in the study
• • Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study
• Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:
• • Prostate adenocarcinoma confirmed by biopsy and histopathological examination
• • After radical treatment
• • In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \<3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or
• • In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml
• • Age ≥18 years
• • Signing informed consent
• Exclusion Criteria:
• • Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination
• • Claustrophobia
• • Patient size precluding PET / MR examination due to diameter gantry
• • Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)
• • Treatment for malignant neoplasm not associated with the prostate gland
• • Participating in another clinical trial
• • Lack of informed consent to participate in the study
• • Age \<18 years