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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Unknown PHASE2 INTERVENTIONAL NCT05555017

Tracer-Guided Surgery for Recurrent Prostate Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.

Detailed Description

Improving the oncological treatment outcomes in men with a biochemical recurrence after primary prostate cancer (PC) treatment that are diagnosed with a disease recurrence confined to the regional lymph nodes or local residual disease using Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography and Computed Tomography (PET/CT.) The proposed trial randomizes patients with recurrent PC following primary PC treatment to either 6 months of ADT or Technetium-PSMA-radioguided salvage surgery plus 6 months of ADT. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms.

Interventions

Name: PSMA-radioguided surgery
Type: PROCEDURE
Description: Approximately 15-24 hours prior to surgery, 400-600 Megabecquerel (MBq) of 99mTc-PSMA-I\&S will be intravenously administered to the patient at the Nuclear Medicine department. Following this injection patients will be allowed to return home, and then present for their 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery the next day.
Name: ADT
Type: DRUG
Description: Standard 6 months of ADT according to current clinical guidelines. ADT consists of one subcutaneous depot of 22,5mg triptorelin (Pamorelin), with 4 weeks bicalutamide 50mg per os from 2 weeks before till 2 weeks after the first Pamorelin administration.

Primary Outcomes

Measure: Clinical progression-free survival (CPFS)
TimeFrame: 24 months
Description: CPFS is defined as time between randomization and the appearance of a recurrence (any N1 or M1) as suggested by PSMA PET/CT or symptoms related to progressive PC, or death due to any cause

Trial Information

NCT ID

NCT05555017

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

The Netherlands Cancer Institute

Last Updated

December 15, 2025