Multicentre, Phase 3 Trial to Determine Diagnostic Value of 68Ga-PSMA-11 (in PET/CT and PET/MRI) in Intermediate and High-Risk Prostate Cancer Patients before Introduction of Radical Treatment and in Patients Diagnosed with Biochemical Failure Following Radical Treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Bialystok

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Dec 2022 → 31 Mar 2026

Decision date (initial)

2024-12-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-516556-17-00

EudraCT number

2021-004257-24

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Efficacy, Dose response, Therapy

Determination of diagnostic applications of 68Ga-PSMA-11 (in PET/CT and PET/MRI) for staging of prostate cancer and precise location of neoplastic lesions

Secondary objectives 6

1. To compare incidence of treatment plan alterations following standard diagnostics 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
2. To compare incidence of relapse location following standard diagnostics, 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI (Group 2 only)
3. To determine concentration of Prostate Specific Antigen (PSA) justifying 68Ga-PSMA-11 PET/MRI (Group 2 only)
4. To assess and compare safety of 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
5. To assess and compare absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
6. To assess pharmacoeconomic data (compare costs of procedures planned after visit 1 and those actually performed after the investigated diagnostics were carried out)

Conditions and MedDRA coding

Intermediate and high-risk prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Signed informed consent to participate in the study
2. Age ≥18 years
3. Group 1: patients with a diagnosis or high probability of CRC of intermediate and high risk according to ISUP, in whom it is planned to implement radical treatment
4. Group 1: Prostate adenocarcinoma confirmed by biopsy and histopathology or negative BAC with mpMR and PSA results indicating n high risk of RGK
5. Group 1: Results indicative of intermediate-risk 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
6. Group 1: Creatinine value that allows the study to be performed safely PET/MR with contrast agent: creatinine less than or equal to 1.5x the upper limit of normal, creatinine clearance >60 mL/min
7. Group 1: Performed pelvic/prostate mpMR examination, no earlier than 90 days prior to inclusion in the project
8. Group 1: Status after prostate BAC (results may be inconclusive)
9. Group 2: Patients with CRC after radical treatment, with recurrence of biochemical according to EAU criteria, in whom further treatment is planned, and the imaging/molecular test results may change the therapeutic decision therapeutic decision:
10. Group 2: Prostate adenocarcinoma confirmed by biopsy or histopathological examination
11. Group 2: After radical treatment
12. Group 2: For patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng/ml not earlier than 6 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months. PSA in at least two consecutive tests within the last 6 months before eligibility (last determination within 6 weeks before eligibility, not necessary to do on the day of the visit))
13. Or: for patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng/ml (we consider the lowest PSA concentration during ADT + 2ng/ml)
14. Or: if radical treatment included the inclusion of hormone therapy: three consecutive PSA increases, at least two of which measured with an increase of at least 50% above the nadir level, and a current PSA > 2 ng/mL

Exclusion criteria 9

1. Lack of informed consent to participate in the study
2. Age < 18 years
3. The presence of metallic foreign bodies/implants/prostheses/stimulators, etc. inside the body, the possession of which is a contraindication to the 3T MR examination
4. Claustrophobia
5. Patient sizes preventing PET/MR study due to gantry diameter. In cases of doubt, consultation with the research center Bialystok or Bydgoszcz, respectively, is advisable
6. Known contraindications to the use of radiopharmaceutical products or excipients (e.g., renal failure and allergy to the ingredients of the preparation)
7. Hormone therapy (applies to group 1 only)
8. Treatment for malignant neoplasm unrelated to the prostate gland (skin cancer) within the last 5 years.
9. Participation in another clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Percentage of patients for whom, following 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI and precise location of neoplastic lesions, prostate cancer staging was changed according to ISUP and TNM classification
2. Percentage of patients, in whom, with 68Ga-PSMA PET/MRI and 68Ga-PSMA location of prostate cancer relapse was detected (detection rate) – Study Group 2 only

Secondary endpoints 6

1. Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts an alteration of the treatment plan
2. Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts finding of the relapse location (Group 2 only)
3. PSA levels, with which the relapse location was found with 68Ga-PSMA-11 PET/MRI (Group 2 only)
4. Number and type of serious adverse effects reported during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
5. Mean absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
6. Pharmacoeconomic data (cost of procedures planned to be performed after visit 1 and those actually performed after the investigated diagnostics were carried out)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Bialystok

Sponsor organisation

Medical University Of Bialystok

Address

Ul. Jana Kilinskiego 1

City

Bialystok

Postcode

15-089

Country

Poland

Scientific contact point

Organisation

Medical University Of Bialystok

Contact name

Department of Oncology

Public contact point

Organisation

Medical University Of Bialystok

Contact name

Department of Oncology

Third parties 3

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications