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)

September 21, 2023 updated by: Medical University of Bialystok
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ewa Sierko, Professor
  • Phone Number: 85 664 67 83
  • Email: ewa.sierko@iq.pl

Study Contact Backup

  • Name: Clinical Research Support Center Medical University of Bialystok
  • Phone Number: 85 686 53 86

Study Locations

  • Poland
      • Białystok, Poland, 15-027
        • Recruiting
        • Białystok Oncology Center Maria Skłodowska-Curie
        • Contact:
      • Białystok, Poland, 15-276
        • Recruiting
        • University Clinical Hospital in Białystok
        • Contact:
      • Białystok, Poland, 15-471
        • Not yet recruiting
        • Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
        • Contact:
      • Białystok, Poland, 15-540
        • Recruiting
        • Laboratory of Molecular Imaging and Technology Development
        • Contact:
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
        • Contact:
      • Lublin, Poland, 20-090
        • Recruiting
        • Center of Oncology of the Lublin Region St. Jana z Dukli
        • Contact:
      • Łódź, Poland, 93-513
        • Not yet recruiting
        • Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1- patient of middle and high risk of prostate cancer
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].
Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Active Comparator: Group 2- patient after radical treatment, at relapse biochemical
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
Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT
Time Frame: 24 months
Validation of the diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in the assessment stage of prostate cancer and precise assessment of the location of neoplastic changes.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishing a therapeutic path depending on the PET/MR and PET/CT
Time Frame: 24 months
Percentage of patients with 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR will lead to a change in the therapeutic path
24 months
Detection of the site of recurrence
Time Frame: 24 months
Comparison of the frequency of detecting the site of recurrence after examination with standard methods, 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR (only for the second group)
24 months
Determination of PSA concentration
Time Frame: 24 months
Determination of the PSA concentration at which the 68Ga-PSMA-11 PET / MR test enables detection of local or regional recurrence (only for the second group)
24 months
Number of participants with adverse events related to 68Ga-PSMA-11
Time Frame: 24 months

Serious adverse events are not expected. The radiotracer 68Ga-PSMA-11 is dose by the intravenous route in trace amounts and does not affect the patient's well-being.

The use of 68Ga-PSMA-11 is contraindicated in kidney failure and allergies to the ingredients of the preparation (all patients will have their serum creatinine measured before the test).
24 months
Absorbed radiation dose
Time Frame: 24 months
Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR
24 months
Evaluation of pharmacoeconomic data
Time Frame: 24 months
Comparison of the costs of the procedures planned for performance after the first visit, and those that were actually made after conducting the assessed tests
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Collaborators

Medical Research Agency, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/ABM/01/00074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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