Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial

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 th

Trial Details

NCT ID

NCT07650240

Phase

PHASE2

Sponsor

Mayo Clinic

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

Abiraterone Acetate
Biospecimen Collection
Leuprolide Acetate
Lutetium Lu 177 Vipivotide Tetraxetan
Prednisone
PSMA PET-CT Scan

Locations (sample)

Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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