PSMA PET-based 3D mixed-reality navigation for pelvic lymph node removal in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective feasibility project that creates a patient-specific 3D mixed-reality model from preoperative PSMA PET imaging and uses it before and after surgery as a navigation and educational tool. Surgeons, the surgical team, and patients will review the model during consultations, and robot-assisted procedures will be recorded to capture instrument position and video data. Investigators will analyze how 3D visualization affects instrument movement and the efficiency of targeted lymph node resection and will develop two navigation methods (landmark-based registration and visual tracking) using the imaging and instrument data. Short-term oncologic outcomes (PSA response) and patient quality-of-life measures will be collected to indicate successful removal of PSMA-PET-positive lesions and patient impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Cohort A:

* Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection
* \<3 PSMA-PET-avid lymph node metastases (PSMA expression score \>2) in the pelvis.

Cohort B:

* Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection
* \<3 PSMA-PET-avid lymph node metastases (PSMA expression score \>2) in the pelvis
* PSA value \<2ng/ml.

Exclusion Criteria:

* Estimated life expectancy \<10 years
* contraindication for surgical intervention
* androgen deprivation therapy (ADT) within the last 3 months

Where it's running

• Martini-Klinik
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
• Anke Renter
  Hamburg, Free and Hanseatic City of Hamburg, Germany Not yet recruiting

Study contacts

• Study coordinator: Tobias Maurer, Professor
• Email: t.maurer@uke.de
• Phone: +4940741053115

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback

  Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.

  Recruiting at 4 sites Shanghai Zhongshan Hospital · Shanghai and 3 other locations · NCT07856017

• MRT-2359 plus apalutamide in advanced prostate cancer

  This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.

  Recruiting at 7 sites Phase 2 Monte Rosa Therapeutics, Inc · Los Angeles, California and 13 other locations · NCT07745361

• Predicting prostate cancer response to neoadjuvant darolutamide with a gene biomarker

  This study tests whether a gene-based PCAI ImmunoScore can predict which high-risk localized or locally advanced prostate cancer patients will have minimal residual disease after 90–120 days of darolutamide before surgery.

  Recruiting at 2 sites Phase 2 Region Stockholm · Gothenburg and 1 other locations · NCT07617272

• Personal preferences for avoiding gynecomastia (Stage 1)

  This project will ask men with prostate cancer and high-risk biochemical recurrence what trade-offs they'd make to avoid breast-related side effects like gynecomastia.

  Recruiting St Vincent's Hospital, Sydney · Sydney, New South Wales · NCT07552922

• LaserSAFE: Quick in OR imaging to check margins during prostatectomy

  A new in‑the‑operating‑room imaging method called LaserSAFE is tested to see if it can quickly detect cancer at the edge of the prostate during surgery for patients undergoing robot-assisted prostatectomy.

  Recruiting University College, London · London · NCT07541911

• Early postoperative PSA after prostate removal as a predictor of cancer outcomes

  We will test whether early PSA levels after prostate removal can help predict long-term cancer outcomes in men undergoing radical prostatectomy.

  Recruiting Lithuanian University of Health Sciences · Kaunas, Kauno · NCT07516886

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.