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

Prostate Cancer Clinical Trial

— PROSPETMR2021  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582876
• Other study ID #: 2020/ABM/01/00074
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: Medical University of Bialystok
• Contact: Ewa Sierko, Professor
• Phone: 85 664 67 83
• Email: ewa.sierko[@]iq.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: November 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Poland	Bialystok Oncology Center Maria Sklodowska-Curie	Bialystok
Poland	Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Bialystok	Bialystok
Poland	Laboratory of Molecular Imaging and Technology Development	Bialystok
Poland	University Clinical Hospital in Bialystok	Bialystok
Poland	Oncology Center named after prof. F. Lukaszczyk in Bydgoszcz	Bydgoszcz
Poland	Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Lódz	Lódz
Poland	Center of Oncology of the Lublin Region St. Jana z Dukli	Lublin

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Bialystok	Medical Research Agency, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT	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	Establishing a therapeutic path depending on the PET/MR and PET/CT	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
Secondary	Detection of the site of recurrence	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
Secondary	Determination of PSA concentration	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
Secondary	Number of participants with adverse events related to 68Ga-PSMA-11	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
Secondary	Absorbed radiation dose	Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR	24 months
Secondary	Evaluation of pharmacoeconomic data	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