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 (PROSPETMR2021)

Medical University of Bialystok

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05582876

2020/ABM/01/00074

Details and patient eligibility

About

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

Enrollment: 366 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 2 patient groups

Group 1- patient of middle and high risk of prostate cancer

Active Comparator group

Description:

Patients with diagnosis or high probability of prostate cancer medium and high risk according to ISUP for which implementation is planned radical treatment \[i.e. PSA≥10 ng / ml or GS ≥ 7 (ISUP ≥2) or ≥cT2b\].

Treatment:

Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT

Group 2- patient after radical treatment, at relapse biochemical

Active Comparator group

Description:

Prostate cancer patients after radical treatment, with recurrence biochemical tests according to the criteria of the European Society of Urology (EAU, European Association of Urology) \[at least double measurement PSA ≥0.2 ng / ml not earlier than 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \<3 months or increase in PSA after radical radiotherapy\> 2 ng / ml above PSAnadir - the lowest PSA value found after the test treatment\] for whom further treatment is planned and the test result imaging / molecular imaging may alter the therapeutic decision

Treatment:

Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT