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NCT07650240 · ClinicalTrials.gov registry record · Phase 2
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
A Phase 2 study, sponsored by Mayo Clinic.
- Not yet
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
NCT07650240: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT07650240 is a Phase 2 study that has not yet begun recruiting, run by Mayo Clinic. The registered enrollment target is 202 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07650240, a Phase 2 study, has not yet begun recruiting, sponsored by Mayo Clinic.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Prednisone
- DRUG Abiraterone Acetate
- DRUG Leuprolide Acetate
- DRUG Lutetium Lu 177 Vipivotide Tetraxetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-12-30 |
| Phase | Phase 2 |
What is known before NCT07650240 opens enrollment
NCT07650240 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07650240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07650240 about?
NCT07650240 is a clinical study titled "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 volu...
What is the current status of trial NCT07650240?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2026-07-01. Estimated completion is 2030-12-30.
What interventions are being tested in trial NCT07650240?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Prednisone (DRUG), Abiraterone Acetate (DRUG), Leuprolide Acetate (DRUG), Lutetium Lu 177 Vipivotide Tetraxetan (DRUG).
Who is sponsoring clinical trial NCT07650240?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07650240's enrollment target sits among peer trials
202 301st of 2000 higher than 1,699 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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