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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07650240
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • De Novo Low Volume Metastatic Castration-Sensitive Prostate Adenocarcinoma
  • Recurrent Castration-Sensitive Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone Acetate — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Leuprolide Acetate — DRUG
    Given SC
  • Lutetium Lu 177 Vipivotide Tetraxetan — DRUG
    Given IV
  • Prednisone — DRUG
    Given PO
  • PSMA PET-CT Scan — PROCEDURE
    Undergo PSMA PET/CT
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2030
Completion
Dec 30, 2030

Study Design

Enrollment
202 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A1 (177Lu-PSMA-617, iADT)
    Patients receive 177Lu-PSMA-617 IV once every 6 weeks and leuprolide acetate SC 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.
  • Active Comparator: Arm A2 (iADT)
    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.
  • Experimental: Arm B1 (177Lu-PSMA-617, iADT, iAA, P)
    Patients receive 177Lu-PSMA-617 IV every 6 weeks, 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 and undergo SPECT on study.
  • Active Comparator: Arm B2 (iADT, iAA, P)
    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.

Primary Outcome Measure

Radiographic progression free survival (rPFS) [ Time Frame: At 18 months ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • Urology Study Coordinator
    507-422-5076

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Urology Study Coordinator
507-422-5076
Matthew K. Tollefson, MD (PRINCIPAL_INVESTIGATOR)

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