A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer
Mayo Clinic
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Male patients aged 18 years or older * Signed informed consent must be obtained prior to participation in the study * Histologically confirmed adenocarcinoma of the prostate * Prior treatment with radical prostatectomy or radiation therapy for localized disease is required * Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if: * The last treatment \> 12 months from enrollment on the trial * The duration of treatment is less than 3 months and no evidence of disease progression on treatment * Disease detecte…
Interventions
- DrugAbiraterone Acetate
Given PO
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugLeuprolide Acetate
Given SC
- DrugLutetium Lu 177 Vipivotide Tetraxetan
Given IV
- DrugPrednisone
Given PO
- ProcedurePSMA PET-CT Scan
Undergo PSMA PET/CT
- OtherQuality-of-Life Assessment
Ancillary studies
- ProcedureSingle Photon Emission Computed Tomography
Undergo SPECT
Location
- Mayo Clinic in RochesterRochester, Minnesota