177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: POINT Biopharma

Criteria

Inclusion Criteria:

• Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers

• Age >= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• No indication for urgent or emergent radiation

• Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable)

• White blood cell count >= 2.5 × 10^9/L

• Platelets >= 100 × 10^9/L

• Hemoglobin >= 9 g/dL

• Total bilirubin =< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN if known history of Gilbert's syndrome

• Alanine aminotransferase or aspartate aminotransferase =< 3.0 × ULN or =< 5.0 × ULN for patients with liver metastases

• Serum creatinine =< 1.5 × ULN or creatinine clearance >= 50 mL/min

• Serum albumin > 3.0 g/dL

• Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration

• Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

• Patients with neuroendocrine or small cell carcinoma of the prostate

• Patients with castrate-resistant disease (i.e., PSA > 0.5 ng/mL with serum testosterone < 150 ng/dL)

• Patients who received androgen deprivation therapy within 6 months of trial enrollment

• Concurrent systemic therapy for a solid organ malignancy

• Spinal cord compression

• Inability to lie flat

• Known hypersensitivity to components of 177Lu-PNT2002

• Serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min

• Total bilirubin > 1.5 × ULN or > 3.0 × ULN if known history of Gilbert's syndrome

• Alanine aminotransferase or aspartate aminotransferase > 3 × ULN (or 5 × ULN for patients with known liver metastases)

• De novo oligometastatic disease