Trials / Unknown
UnknownNCT05555017
Tracer-Guided Surgery for Recurrent Prostate Cancer
Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | PSMA-radioguided surgery | 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. |
| DRUG | ADT | 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. |
Timeline
- Start date
- 2023-02-15
- Primary completion
- 2024-11-01
- Completion
- 2025-11-01
- First posted
- 2022-09-26
- Last updated
- 2023-10-06
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05555017. Inclusion in this directory is not an endorsement.