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

Running, not enrolling · Phase 2

Conditions studied: Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT05496959

Run by

Jonsson Comprehensive Cancer Center

People needed

93

Starts

2022-09-02

Expected to finish

2033-09-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.