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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Poland
Białystok Oncology Center Maria Skłodowska-Curie
RECRUITING
Bialystok
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
NOT_YET_RECRUITING
Bialystok
Laboratory of Molecular Imaging and Technology Development
RECRUITING
Bialystok
University Clinical Hospital in Białystok
RECRUITING
Bialystok
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
RECRUITING
Bydgoszcz
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
NOT_YET_RECRUITING
Lodz
Center of Oncology of the Lublin Region St. Jana z Dukli
RECRUITING
Lublin
Contact Information
Primary
Ewa Sierko, Professor
ewa.sierko@iq.pl
85 664 67 83
Backup
Clinical Research Support Center Medical University of Bialystok
85 686 53 86
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 366
Treatments
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 \[i.e. PSA≥10 ng / ml or GS ≥ 7 (ISUP ≥2) or ≥cT2b\].
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
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Agency, Poland
Leads: Medical University of Bialystok

This content was sourced from clinicaltrials.gov