NCT04300673: DETECT

Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients

Status unknown Phase 1, PHASE2 Last updated 29 April 2022

What this trial tests

Phase 1, PHASE2 trial testing Radio guided surgery (RGS) using Indium-labelled PSMA in Prostate Cancer in 20 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	1 September 2020
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	2 locations across Netherlands

Drugs / interventions tested

• Radio guided surgery (RGS) using Indium-labelled PSMA

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Lymph Node Metastases — all drugs for Lymph Node Metastases →

Sponsor

Radboud University Medical Center

Who can join

50 and older, male only, with Prostate Cancer or Lymph Node Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastases based on pre-operative imaging.

Patients with prostate cancer who have a high risk of lymph node metastases based on PSMA PET/CT and scheduled for robot-assisted PLND (with or without prostatectomy) will be recruited. Eligible patients will receive an additional ferumoxtran-10 enhanced MRI to complement pre-operative imaging. Twenty-four hours before surgery, patients will receive the radiolabelled PSMA tracer. Pelvic Lymph node dissections are carried out according to standard of care procedures. During surgery, the surgeon will be provided with a gamma-probe to detect PSMA expressing lymph nodes in vivo. Dissected samples will be systematically assessed on tracer accumulation using the gamma-probe ex vivo. After surgery, the samples will be scanned in the small animal SPECT/CT and 7T-MRI. After scanning, samples will be presented to pathologists for pathological analysis according to standard of care including staining for PSMA expression. At 3 months after surgery, patients will undergo a PSMA-PET/CT. Up until one year after surgery patients will be followed according to standard of care-guidelines by 3-monthly serum-PSA measurements.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer nanotechnology: current status and perspectives.
   Kemp JA, Kwon YJ. · · 2021 · cited 117× · PMID 34727233 · DOI 10.1186/s40580-021-00282-7
2. Radiometals in Imaging and Therapy: Highlighting Two Decades of Research.
   Sharma S, Pandey MK. · · 2023 · cited 13× · PMID 37895931 · DOI 10.3390/ph16101460
3. Role of PSMA PET-guided metastases-directed therapy in oligometastatic recurrent prostate cancer.
   Alberto M, Yim A, Papa N, Siva S, et al · · 2022 · cited 11× · PMID 36059632 · DOI 10.3389/fonc.2022.929444
4. How Image-Guided Pathology Can Improve the Detection of Lymph Node Metastases in Prostate Cancer.
   Schilham MGM, Küsters-Vandevelde H, Somford DM, Rijpkema M, et al · · 2022 · cited 3× · PMID 35439175 · DOI 10.1097/rlu.0000000000004158
5. A Personalized Approach for Oligometastatic Prostate Cancer: Current Understanding and Future Directions.
   Alerasool P, Zhou S, Miller E, Anker J, et al · · 2025 · cited 1× · PMID 39796774 · DOI 10.3390/cancers17010147