NCT05582876

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
366

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

3.1 years

First QC Date

October 11, 2022

Last Update Submit

May 5, 2025

Conditions

Prostate Cancer

Keywords

PET/CTPET/MR68Ga-PSMA-11PSA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Establishing a therapeutic path depending on the PET/MR and PET/CT

    24 months

  • Detection of the site of recurrence

    24 months

  • Determination of PSA concentration

    24 months

  • Number of participants with adverse events related to 68Ga-PSMA-11

    24 months

  • Absorbed radiation dose

    24 months

  • +1 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR

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

Group 2- patient after radical treatment, at relapse biochemical

ACTIVE COMPARATOR

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

Interventions

Radiopharmaceutical 68Ga-PSMA-11 PET/CTRADIATION

The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.

Group 1- patient of middle and high risk of prostate cancerGroup 2- patient after radical treatment, at relapse biochemical

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Białystok Oncology Center Maria Skłodowska-Curie

Bialystok, 15-027, Poland

RECRUITING

University Clinical Hospital in Białystok

Bialystok, 15-276, Poland

RECRUITING

Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok

Bialystok, 15-471, Poland

NOT YET RECRUITING

Laboratory of Molecular Imaging and Technology Development

Bialystok, 15-540, Poland

RECRUITING

Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz

Bydgoszcz, 85-796, Poland

RECRUITING

Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź

Lodz, 93-513, Poland

NOT YET RECRUITING

Center of Oncology of the Lublin Region St. Jana z Dukli

Lublin, 20-090, Poland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Ewa Sierko, Professor

CONTACT

85 664 67 83ewa.sierko@iq.pl

Clinical Research Support Center Medical University of Bialystok

CONTACT

85 686 53 86

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 17, 2022

Study Start

January 10, 2023

Primary Completion

January 31, 2026

Study Completion

March 31, 2026

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations

PL(7)