Navigation, outcomes and quality-of-life in prostate cancer patients undergoing PSMA-targeted surgery

Navigation, outcomes and quality-of-life in prostate cancer patients undergoing PSMA-targeted surgery - NICE-PSMA-Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037627

Enrollment

102

Registered

2025-08-08

Start date

2026-01-12

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of

Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-

only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated

Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examin

Eligibility

Sex/Gender

Male

Age

18 Years to 78 Years

Inclusion criteria

Inclusion criteria: Cohort A: Patients with hormone-sensitive prostate cancer scheduled for radical prostatectomy with pelvic lymph node dissection, 2) in the pelvis. Cohort B: Patients with hormone-sensitive recurrent prostate cancer after radical prostatectomy with planned pelvic salvage lymph node dissection, 2) in the pelvis, PSA value <2ng/ml.

Exclusion criteria

Exclusion criteria: Estimated life expectancy <10 years, contraindication for surgical intervention, androgen deprivation therapy (ADT) within the last 3 months

Design outcomes

Primary

Measure	Time frame
To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan). The 3D model is used for surgical guidance during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B). The postoperative histology of the specifically dissected tissue serves as a reference.	—

Measure

Time frame

To evaluate the detection rate of lymph node metastases using PSMA-targeted surgery with or without a virtual 3D model (the preoperative PSMA PET scan). The 3D model is used for surgical guidance during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B). The postoperative histology of the specifically dissected tissue serves as a reference.

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Secondary

Measure	Time frame
Feasibility and accuracy of preoperative virtual 3D modeling for patient consultation and surgical planning (determined by pre- and postoperative standardized User Experience Questionnaire (UEQ) and Mixed reality Questionnaire). Retrospective analysis of vision-based and robotic tracking methods for target detection and retrospective analysis of the efficiency of PSMA-targeted dissection based on instrument tracking information (in robotic surgery). Diagnostic accuracy of PSMA-PET-CT for detection of lymph node metastases during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B) with post-operative histology of all dissected specimens as reference. Short-term oncologic outcomes (complete biochemical response (cBR), defined as a PSA level <0.2 ng/mL at 8-12 weeks (Cohort A) or 4-6 weeks (Cohort B)). Quality of life (SF-12, EPIC-26), morbidity (intra- and postoperative complications within 6 months according to the Clavien-Dindo classification) and satisfaction (Decision Regret Scale) after PSMA-targeted surgery for primary prostatectomy and pelvic lymph node dissection (cohort A) or after salvage lymph node dissection (cohort B) with/without preoperative guidance of the virtual 3D model.	—

Measure

Time frame

Feasibility and accuracy of preoperative virtual 3D modeling for patient consultation and surgical planning (determined by pre- and postoperative standardized User Experience Questionnaire (UEQ) and Mixed reality Questionnaire). Retrospective analysis of vision-based and robotic tracking methods for target detection and retrospective analysis of the efficiency of PSMA-targeted dissection based on instrument tracking information (in robotic surgery). Diagnostic accuracy of PSMA-PET-CT for detection of lymph node metastases during open/robotic primary prostatectomy with pelvic lymph node dissection (Cohort A) or open/robotic salvage lymph node dissection (SLND) for recurrent prostate cancer (Cohort B) with post-operative histology of all dissected specimens as reference. Short-term oncologic outcomes (complete biochemical response (cBR), defined as a PSA level <0.2 ng/mL at 8-12 weeks (Cohort A) or 4-6 weeks (Cohort B)). Quality of life (SF-12, EPIC-26), morbidity (intra- and postoperative complications within 6 months according to the Clavien-Dindo classification) and satisfaction (Decision Regret Scale) after PSMA-targeted surgery for primary prostatectomy and pelvic lymph node dissection (cohort A) or after salvage lymph node dissection (cohort B) with/without preoperative guidance of the virtual 3D model.

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Countries

Germany

Contacts

Public ContactTobias Maurer

Martini-Klinik am UKE GmbH

t.maurer@uke.de+4940741053115

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026