NCT05582876 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
| NCT ID | NCT05582876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Bialystok |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 366 participants |
| Start Date | 2023-01-10 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 366 participants in total. It began in 2023-01-10 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05582876 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 99 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05582876 currently recruiting?
Yes, NCT05582876 is actively recruiting participants. Contact the research team at ewa.sierko@iq.pl for enrollment information.
Where is the NCT05582876 trial being conducted?
This trial is being conducted at Bialystok, Poland, Bialystok, Poland, Bialystok, Poland, Bialystok, Poland and 3 additional locations.
Who is sponsoring the NCT05582876 clinical trial?
NCT05582876 is sponsored by Medical University of Bialystok. The trial plans to enroll 366 participants.
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