This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Given PO
Undergo collection of blood samples
Given SC
Given IV
Given PO
Undergo PSMA PET/CT
Ancillary studies
Undergo SPECT
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGRadiographic progression free survival (rPFS)
Will be evaluated according to prostate specific membrane antigen (PSMA) positron emission tomography (PET) progression (PPP) criteria. Defined as the time from enrollment to documented radiographic progression or death from any cause, whichever occurs first.
Time frame: At 18 months
Biochemical recurrence free survival (BCR-FS)
Assessed using PSMA scans. Defined as the time after treatment during which no signs of biochemical recurrence are found.
Time frame: At 12 months
Treatment-free interval
Defined as the length of time a patient remains off active systemic therapies while maintaining disease control.
Time frame: Up to 18 months
Overall survival
Defined as the time from randomization or enrollment to death from any cause, whichever occurs first.
Time frame: Up to 3 years
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