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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)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Radiopharmaceutical 68Ga-PSMA-11 PET/CT
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring PET/CT, PET/MR, 68Ga-PSMA-11, PSA

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Białystok Oncology Center Maria Skłodowska-CurieRecruiting
  • University Clinical Hospital in BiałystokRecruiting
  • Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
  • Laboratory of Molecular Imaging and Technology DevelopmentRecruiting
  • Oncology Center named after prof. F. Łukaszczyk in BydgoszczRecruiting
  • Center of Oncology of the Lublin Region St. Jana z DukliRecruiting
  • Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

Group 2- patient after radical treatment, at relapse biochemical

Arm Description

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].

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)
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)
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).
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
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

Full Information

First Posted
October 11, 2022
Last Updated
September 21, 2023
Sponsor
Medical University of Bialystok
Collaborators
Medical Research Agency, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05582876
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
Collaborators
Medical Research Agency, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PET/CT, PET/MR, 68Ga-PSMA-11, PSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1- patient of middle and high risk of prostate cancer
Arm Type
Active Comparator
Arm Description
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].
Arm Title
Group 2- patient after radical treatment, at relapse biochemical
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiopharmaceutical 68Ga-PSMA-11 PET/CT
Intervention Description
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Primary Outcome Measure Information:
Title
Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Establishing a therapeutic path depending on the PET/MR and PET/CT
Description
Percentage of patients with 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR will lead to a change in the therapeutic path
Time Frame
24 months
Title
Detection of the site of recurrence
Description
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)
Time Frame
24 months
Title
Determination of PSA concentration
Description
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)
Time Frame
24 months
Title
Number of participants with adverse events related to 68Ga-PSMA-11
Description
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).
Time Frame
24 months
Title
Absorbed radiation dose
Description
Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR
Time Frame
24 months
Title
Evaluation of pharmacoeconomic data
Description
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
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewa Sierko, Professor
Phone
85 664 67 83
Email
ewa.sierko@iq.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Support Center Medical University of Bialystok
Phone
85 686 53 86
Facility Information:
Facility Name
Białystok Oncology Center Maria Skłodowska-Curie
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorota Kazberuk, PhD
Phone
85 66 46 718
Email
dkazberuk@onkologia.bialystok.pl
Facility Name
University Clinical Hospital in Białystok
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Sierko, Professor
Phone
85 831 8284
Email
ewa.sierko@iq.pl
Facility Name
Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
City
Białystok
ZIP/Postal Code
15-471
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lech Gałek, PhD
Phone
(47) 710 40 01
Email
lgalek@zozmswia.bialystok.pl
Facility Name
Laboratory of Molecular Imaging and Technology Development
City
Białystok
ZIP/Postal Code
15-540
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Małgorzata Mojsak, PhD
Phone
85 500 10 20
Email
malgorzata.mojsak@umb.edu.pl
Facility Name
Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Małkowski, Professor
Phone
52-374-34-28
Email
malkowskib@co.bydgoszcz.pl
Facility Name
Center of Oncology of the Lublin Region St. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mateusz Bilski, MD
Phone
814 541 375
Email
bilskimat@gmail.com
Facility Name
Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Fijuth, Professor
Phone
42 689 55 55
Email
jacekf@kopernik.lodz.pl

12. IPD Sharing Statement

Learn more about this trial

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

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