A Phase 2 interventional study of Abiraterone Acetate and Biospecimen Collection in Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 and Castration-Sensitive Prostate Cancer, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
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This study's planned enrollment of 202 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
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Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:
Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET/CT is defined as:
=\< 10 total metastatic spots
Exclusion Criteria:
Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study
Patients receive 177Lu-PSMA-617 IV once every 6 weeks and leuprolide acetate subcutaneous (SC) once every 3 months (Q3M). Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo PSMA PET/CT and collection of blood samples throughout the trial and undergo SPECT on study.
Procedure: Biospecimen Collection · Drug: Leuprolide Acetate · Drug: Lutetium Lu 177 Vipivotide Tetraxetan · Procedure: PSMA PET-CT Scan · Other: Quality-of-Life Assessment · Procedure: Single Photon Emission Computed Tomography
Patients receive leuprolide acetate SC Q3M for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo PSMA PET/CT and collection of blood samples throughout the trial.
Procedure: Biospecimen Collection · Drug: Leuprolide Acetate · Procedure: PSMA PET-CT Scan · Other: Quality-of-Life Assessment
Patients receive 177Lu-PSMA-617 IV every 6 weeks, leuprolide acetate SC Q3M, abiraterone acetate PO (by mouth) QD (once a day) and prednisone PO BID (twice a day). Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo PSMA PET/CT and collection of blood samples throughout the trial and undergo SPECT on study.
Drug: Abiraterone Acetate · Procedure: Biospecimen Collection · Drug: Leuprolide Acetate · Drug: Lutetium Lu 177 Vipivotide Tetraxetan · Drug: Prednisone · Procedure: PSMA PET-CT Scan · Other: Quality-of-Life Assessment · Procedure: Single Photon Emission Computed Tomography
Patients receive leuprolide acetate SC Q3M, abiraterone acetate PO QD and prednisone PO BID. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo PSMA PET/CT and collection of blood samples throughout the trial.
Drug: Abiraterone Acetate · Procedure: Biospecimen Collection · Drug: Leuprolide Acetate · Drug: Prednisone · Procedure: PSMA PET-CT Scan · Other: Quality-of-Life Assessment
Given PO
Also known as: BR9004, BR9004-1, CB 7630, CB-7630, CB7630, JNJ-212082, Yonsa, Zytiga
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Given SC
Also known as: A 43818, A-43818, A43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Fensolvi, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Luprodex Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP 144, TAP-144, TAP144, Trenantone, Uno-Enantone, Viadur
Given IV
Also known as: 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto
Given PO
Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Undergo PSMA PET/CT
Also known as: PET-CT (PSMA), Prostate-specific Membrane Antigen PET-CT, PSMA PET-CT
Ancillary studies
Also known as: Quality of Life Assessment
Undergo SPECT
Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Radiographic 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
Quality of life - FACT-P
Assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, a 39-item questionnaire used to measures Health-Related Quality of Life (HRQOL) in prostate cancer patients. Responses to each question are scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Possible total scores range from 0-156, with higher scores indicating better QoL. A drop in the FACT-P total score \>5 points will be considered clinically meaningful.
Time frame: At baseline and then every 3 months up to 1 year
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