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 DISSECTIO

Phase 2

Recruiting

• Conditions: prostate cancer; prostate malignancy; 10038597; 10036958

• Registration Number: NL-OMON52075
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

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
- An mpMRI of the abdomen with a maximum of 12 weeks before study entry
- Deemed clinically fit for 177Lu-PSMA RLT
- eGFR >= 30 mL/min/1.73 m2
- Hemoglobin (Hb) >= 5.6 mmol/L
- Leucocytes >= 3.0 x 109/L
- Thrombocytes >= 100 x 109/l
- Provided informed consent

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
- Patients with signs of M1a-b-c disease on pre-operative PSMA PET/CT
- Prior systemic hormonal therapy (ADT)
- >3 lymph node metastases on preoperative PSMA PET
- Complete urinary incontinence, not willing to have an indwelling urinary
catheter.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>It is hypothesized that neo-adjuvant systematic treatment with 177Lu-PSMA RLT<br /><br>does not impede the timing of the surgical procedure nor the surgical procedure<br /><br>itself. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore, it is hypothesized that systematic treatment with 177Lu-PSMA RLT<br /><br>and concurrent local radical treatment leads to a histological response in the<br /><br>resected prostate specimen and in the resected lymph nodes. At last, it is<br /><br>hypothesized that 177Lu-PSMA RLT leads to a sustained disease-free survival<br /><br>after 12 months in a substantial subset of patients in newly diagnosed, locally<br /><br>advanced, HSPCa with an acceptable toxicity and with a minimal effect on QoL<br /><br>and well-being.</p><br>