177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study
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.
detailed description
PRIMARY OBJECTIVE:
I. To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) versus SBRT plus neoadjuvant lutetium Lu-177 PNT2002 (177Lu-PNT2002), with progression defined on the basis of prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT) scans obtained at standard intervals (12 months and 24 months post-SBRT) or at the time of prostate-specific antigen (PSA)-based biochemical progression, or initiation of salvage therapy or death.
SECONDARY OBJECTIVES:
I. To evaluate disease burden of disease (including local control of irradiated lesions and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease who have not progressed by that point.
II. To assess physician-scored toxicity (Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v 5.0\]) of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.
III. To assess patient-reported quality of life (based on the brief pain inventory scale) after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.
IV. To assess androgen deprivation therapy (ADT)-free survival after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.
V. To determine local control of irradiated lesion at 12 months after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease (based on a scheduled PSMA-PET).
VI. To assess time to locoregional progression, time to distant progression, time to new metastasis, and duration of response after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease (based on standard of care imaging).
CORRELATIVE OBJECTIVES:
I. To enumerate circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic acid (ctDNA) at baseline, 3 months, 6 months, and 12 months after SBRT.
II. To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood monocytes at baseline, 3 months, 6 months, and 12 months after SBRT.
official title
177-Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (Lunar)