Dual

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-07-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

KWF Grant: KWF-PPS grant no 2022-PPS-14852 · NWO-TTW-VICI grant no TTW BGT16141

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Diagnosis, Efficacy, Safety, Pharmacodynamic

To confirm lesion-specific uptake of 99mTc-hPSMA by PCa

Secondary objectives 11

1. To evaluate the safety and tolerability of 99mTc-hPSMA in patients with primary PCa
2. To assess the biodistribution and clearance profile of 99mTc-hPSMA at two different time points post-injection in 5 patients (group A, phase 1) with primary PCa
3. To evaluate if 99mTc-hPSMA aids intraoperative localisation of tumor activity within the prostate during RALP that had previously been detected as positive on PSMA-PET/CT and/or PSMA-SPECT/CT
4. To evaluate if 99mTc-hPSMA can be used to aid in detecting positive surgical margins (PSMs) respec-tive to pathology
5. To register and compare radioactive and fluorescent signal intensities in background and tumor tissue
6. To evaluate the concordance between 99mTc-hPSMA-based PSMA-SPECT/CT and areas that had previously been detected as positive on PSMA-PET/CT
7. To evaluate if 99mTc-hPSMA aids intraoperative localisation of PSMA-positive lymph nodess at the time of ePLND compared to preoperative PSMA-PET/CT and PSMA-SPECT/CT
8. To evaluate the sensitivity and specificity of 99mTc-hPSMA in detecting (small) nodal metastases re-spective to pathology
9. To monitor for biochemical recurrence (BCR) at the first post-operative visit
10. To evaluate the signal-to-background ratio (SBR) of the fluorescent and radioactive signal (in and ex vivo)
11. To assess the surgeons’ dexterity during RALP using a drop-in gamma probe

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male, aged 18 years and older
2. Histopathologically confirmed adenocarcinoma of the prostate
3. Had a routine PSMA PET/CT within 90 days before surgery
4. PSMA avid tumor on PSMA PET/CT
5. Suitable for RALP +ePLND, as per institutional guidelines (no minimum or maximum lesions on PSMA PET)
6. Written and signed informed consent

Exclusion criteria 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The presence of lesion-specific uptake of 99mTc-hPSMA by PCa

Secondary endpoints 12

1. Assessment of adverse events according to CTCv5 for 14 days post-injection
2. Tracer distribution at 1h post-injection (in first 5 patients, group A)
3. Tracer distribution at 15h post-injection (group A+B in all 13 patients)
4. Intra-operative mapping of prostatic tumor focus-ing 99mTc-hPSMA
5. The sensitivity (true positive rate) and specificity (true negative rate) of positive surgical margins (PSMs) identification respective to histopathological analysis
6. Registration of radioactive and fluorescent signal intensities in background and tumor tissue
7. The concordance rate between areas identified as positive on preoperative PSMA-PET/CT and those visible on preoperative PSMA-SPECT/CT
8. 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
9. The sensitivity (true positive rate) and specificity (true negative rate) of 99mTc-hPSMA in detecting nodal metastases respective to histopathological analysis
10. PSA measurement at first postoperative visit (approxi-mately 3-6 months post-operative)
11. The measured signal-to-background ratio (SBR) of the fluorescent and radioactive signals in both in vivo and ex vivo tissues
12. The assessment of surgeons' dexterity during RALP, measured by the movements of the drop-in gamma probe

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Henk van der Poel

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Henk van der Poel

Locations

1 EU/EEA country · 1 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 5 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