An open-label phase 2/3 study to analyse the feasibility and evaluate the safety of intravenous administration of 99mTc-PSMA-T4 in patients with prostate cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowe Centrum Badan Jadrowych

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-519358-35-00

EudraCT number

2021-005113-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

The objective of this study is to evaluate the feasibility and safety of [99mTc]Tc-PSMA-T4 in the diagnosis and treatment planning of prostate cancer and its metastases.

Secondary objectives 1

1. The expected duration of participation for each subject is approximately 17 weeks. This includes up to 4 weeks for screening, 1-2 weeks for diagnostic procedures, and 12 weeks for safety evaluation.

Conditions and MedDRA coding

Feasibility analysis and safety evaluation of [99mTc]Tc-PSMA-T4 in prostate cancer diagnosis and treatment planning.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 18 years of age or older. • PS ECOG < 2 • Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6. • Confirmatory prostate biopsy within 12 weeks (time from pathological diagnosis as PCA date of pathological description to the time of signing the patient's informed consent to participate in the study), only for cohorts A and B. • Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B • Willingness to participate in this study and to provide written informed consent. Additional inclusion criteria for each cohort: Cohort A: • Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer. • Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients. • CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. • No prior treatment for prostate cancer. Cohort B: • High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer. • CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. • No prior treatment for prostate cancer.Cohort C: • Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases.

Exclusion criteria 1

1. A subject will be excluded if ANY of the following criteria are met: • No histopathological confirmation of prostate cancer. • Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer. • Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2x ULN. • Renal impairment including eGFR <30 ml / min. • Within 6 months before inclusion into the study: myocardial infarction, other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute stroke, pulmonary embolism or deep vein thrombosis. • Prior early or locally advanced malignancy after definitive treatment with at least 5-year period without evidence of disease. • Malignancy with distant metastases. • Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block. An active infection that the investigator deems sufficient to exclude the patient from the study, including but not limited to urinary tract infections, respiratory tract infections, and diabetic foot infections with osteomyelitis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation.

Secondary endpoints 1

1. Positive and negative predictive value: Positive predictive value defined as number of true positives x 100% / number of true positives + number of false positives Negative predictive value defined as number of true negatives x 100% / number of true negatives + number of false negatives. Safety: Frequency of adverse events (AEs).The procedure-related AEs will be recorded during the 24h of the follow-up period in each case,no later than 48h after drug administration.Dosimetry, Feasibility.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowe Centrum Badan Jadrowych

Sponsor organisation

Narodowe Centrum Badan Jadrowych

Address

Ul. Andrzeja Soltana 7

City

Otwock

Postcode

05-400

Country

Poland

Scientific contact point

Organisation

Narodowe Centrum Badan Jadrowych

Contact name

Sponsor

Public contact point

Organisation

Narodowe Centrum Badan Jadrowych

Contact name

Sponsor

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

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

Documents 8 files

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

Application history

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