NL-OMON52075
Recruiting
Phase 2
177Lu-PSMA RADIOLIGAND THERAPY IN PATIENTS WITH LYMPH NODE METASTATIC HORMONE-SENSITIVE PROSTATE CANCER UNDERGOING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION - SHEPHERD-trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Men over 18 years of age
- •\- ECOG performance score (PS) 0\-1
- •\- Histologically proven adenocarcinoma of the prostate cancer of any grade
- •and/or stage
- •\- Any prostate\-specific antigen (PSA)\-level
- •\- Planned to undergo radical prostatectomy (RARP) and extended pelvic lymph
- •node dissection (ePLND)
- •\- A pre\-operative \[68Ga] or \[18F] PSMA PET/CT positive for lymphogenic
- •metastatic disease (1\-3 metastases; miN1\) in the surgical template with a
- •maximum of 6 weeks before study entry
Exclusion Criteria
- •\- Previous treatment with any of the following within 6 months of inclusion:
- •Strontium\-89, Samarium\-153, Rhenium\-186, Rhenium\-188, Radium\-223, hemi\-body
- •irradiation
- •\- Previous PSMA\-targeted radioligand therapy
- •\- Any systemic anti\-cancer therapy (e.g., chemotherapy, immunotherapy or
- •biological therapy \[including monoclonal antibodies]) within 28 days prior to
- •day of inclusion
- •\- Known hypersensitivity to the components of the study therapy or its analogs
- •\- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy,
- •or investigational therapy
Outcomes
Primary Outcomes
Not specified
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