99MTC-EUK-(SO3)CY5-MAS3 for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Male, aged 18 years and older"}
• {"criterion_text":"- Histopathologically confirmed adenocarcinoma of the prostate"}
• {"criterion_text":"- Had a routine PSMA PET/CT within 90 days before surgery"}
• {"criterion_text":"- PSMA avid tumor on PSMA PET/CT"}
• {"criterion_text":"- Suitable for RALP +ePLND, as per institutional guidelines (no minimum or maximum lesions on PSMA PET)"}
• {"criterion_text":"- Written and signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Previous radiotherapy of the abdomen"}
• {"criterion_text":"- Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery"}
• {"criterion_text":"- History of other malignancy within 5 years prior to surgery (except skin malignancies)"}
• {"criterion_text":"- Previous or ongoing chemotherapy"}
• {"criterion_text":"- Previous or ongoing immunotherapy"}
• {"criterion_text":"- Severe claustrophobia interfering with PET/CT or SPECT/CT scanning"}
• {"criterion_text":"- History of clinically significant allergies including anaphylaxis"}
• {"criterion_text":"- History of impaired renal function (defined as eGFR<60ml/min/1,73m2)"}

Primary endpoints

• {"endpoint_text":"- The presence of lesion-specific uptake of 99mTc-hPSMA by PCa","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Assessment of adverse events according to CTCv5 for 14 days post-injection","definition_or_measurement_approach":"Assessment of adverse events according to CTCv5 for 14 days post-injection"}
• {"endpoint_text":"- Tracer distribution at 1h post-injection (in first 5 patients, group A)","definition_or_measurement_approach":"Tracer distribution measured at 1 hour post-injection in first 5 patients (group A)"}
• {"endpoint_text":"- Tracer distribution at 15h post-injection (group A+B in all 13 patients)","definition_or_measurement_approach":"Tracer distribution measured at 15 hours post-injection in group A+B (all 13 patients)"}
• {"endpoint_text":"- Intra-operative mapping of prostatic tumor focus-ing 99mTc-hPSMA","definition_or_measurement_approach":""}
• {"endpoint_text":"- The sensitivity (true positive rate) and specificity (true negative rate) of positive surgical margins (PSMs) identification respective to histopathological analysis","definition_or_measurement_approach":"Sensitivity and specificity of PSM identification measured respective to histopathological analysis"}
• {"endpoint_text":"- Registration of radioactive and fluorescent signal intensities in background and tumor tissue","definition_or_measurement_approach":"Registration and comparison of radioactive and fluorescent signal intensities in background and tumor tissue"}
• {"endpoint_text":"- The concordance rate between areas identified as positive on preoperative PSMA-PET/CT and those visible on preoperative PSMA-SPECT/CT","definition_or_measurement_approach":"Concordance rate between preoperative PSMA-PET/CT positive areas and preoperative PSMA-SPECT/CT visible areas"}
• {"endpoint_text":"- The number and location of lymph nodes were identified intra-operatively with 99mTc-hPSMA compared to preoperative PSMA-PET/CT and PSMA SPECT/CT findings","definition_or_measurement_approach":"Comparison of number and location of lymph nodes identified intra-operatively with 99mTc-hPSMA versus preoperative imaging findings"}
• {"endpoint_text":"- The sensitivity (true positive rate) and specificity (true negative rate) of 99mTc-hPSMA in detecting nodal metastases respective to histopathological analysis","definition_or_measurement_approach":"Sensitivity and specificity of 99mTc-hPSMA for detecting nodal metastases measured against histopathology"}
• {"endpoint_text":"- PSA measurement at first postoperative visit (approxi-mately 3-6 months post-operative)","definition_or_measurement_approach":"PSA measured at first postoperative visit approximately 3-6 months post-operative"}
• {"endpoint_text":"- The measured signal-to-background ratio (SBR) of the fluorescent and radioactive signals in both in vivo and ex vivo tissues","definition_or_measurement_approach":"Measured signal-to-background ratio (SBR) for fluorescent and radioactive signals in vivo and ex vivo"}
• {"endpoint_text":"- The assessment of surgeons' dexterity during RALP, measured by the movements of the drop-in gamma probe","definition_or_measurement_approach":"Surgeons' dexterity assessed by movements of the drop-in gamma probe"}

Netherlands

Earliest CTIS Part Ii Submission Date

04-07-2025

Latest Decision Or Authorization Date

11-07-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

13

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"KWF Grant: KWF-PPS grant no 2022-PPS-14852","duties_or_roles":"","organisation_type":""}
• {"country":"","full_name":"NWO-TTW-VICI grant no TTW BGT16141","duties_or_roles":"","organisation_type":""}