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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

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