Prostate CancerPROSPETMR2021NCT05582876
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
A study testing Radiopharmaceutical 68Ga-PSMA-11 PET/CT in people with Prostate Cancer, run by Medical University of Bialystok at 7 sites in Poland.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiopharmaceutical 68Ga-PSMA-11 PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 7 sitesPoland
- Study dates
- 10 Jan 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research Support Center Medical University of Bialystok contact
7 sites in 1 country
Poland7 sites, 7 recruiting
- Recruiting
Białystok Oncology Center Maria Skłodowska-Curie
Bialystok, 15-027
Dorota Kazberuk, PhD, 85 66 46 718, dkazberuk@onkologia.bialystok.pl
- Recruiting
University Clinical Hospital in Białystok
Bialystok, 15-276
Ewa Sierko, Professor, 85 831 8284, ewa.sierko@iq.pl
- Not yet recruiting
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
Bialystok, 15-471
Lech Gałek, PhD, (47) 710 40 01, lgalek@zozmswia.bialystok.pl
- Recruiting
Laboratory of Molecular Imaging and Technology Development
Bialystok, 15-540
Małgorzata Mojsak, PhD, 85 500 10 20, malgorzata.mojsak@umb.edu.pl
- Recruiting
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
Bydgoszcz, 85-796
Bogdan Małkowski, Professor, 52-374-34-28, malkowskib@co.bydgoszcz.pl
- Not yet recruiting
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Lodz, 93-513
Jacek Fijuth, Professor, 42 689 55 55, jacekf@kopernik.lodz.pl
- Recruiting
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, 20-090
Mateusz Bilski, MD, 814 541 375, bilskimat@gmail.com
About this study
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
- Conditions
- Prostate Cancer
- Being tested
- Radiopharmaceutical 68Ga-PSMA-11 PET/CT
- Keywords
- PET/CT, PET/MR, 68Ga-PSMA-11, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: 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 Receives: Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (6)
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
Measured: 24 months
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)
Measured: 24 months
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)
Measured: 24 months
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).
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start10 Jan 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582876
- Sponsor's protocol ID
- 2020/ABM/01/00074
- Acronym
- PROSPETMR2021
- Status last verified
- May 2025
- First submitted
- 11 Oct 2022
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05582876
- Acronym / sponsor ID
- PROSPETMR2021 / 2020/ABM/01/00074
- Conditions
- Prostate Cancer
- Keywords
- PET/CT, PET/MR, 68Ga-PSMA-11, PSA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- patient of middle and high risk of prostate cancer | Active comparator | Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CTPatients 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]. |
| Group 2- patient after radical treatment, at relapse biochemical | Active comparator | Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET/CTProstate 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiopharmaceutical 68Ga-PSMA-11 PET/CTThe radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w. | Radiation | Group 1- patient of middle and high risk of prostate cancer, Group 2- patient after radical treatment, at relapse biochemical |
Primary outcome
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.
6 secondary outcomes
Establishing a therapeutic path depending on the PET/MR and PET/CT
Time frame: 24 months
Detection of the site of recurrence
Time frame: 24 months
Determination of PSA concentration
Time frame: 24 months
Number of participants with adverse events related to 68Ga-PSMA-11
Time frame: 24 months
Absorbed radiation dose
Time frame: 24 months
Evaluation of pharmacoeconomic data
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Research Support Center Medical University of Bialystok contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiopharmaceutical 68Ga-PSMA-11 PET/CT in people with Prostate Cancer, run by Medical University of Bialystok at 7 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ewa Sierko, Professor (85 664 67 83, ewa.sierko@iq.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.