Open Actively Recruiting

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
No
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

Join this Trial

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Study Stats
Protocol No.
22-000750
Category
Oncology
Radiation Oncology
Contact
Carol Felix
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05496959
For detailed technical eligibility, visit ClinicalTrials.gov.