Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku 18 lat lub starsi
- •Potwierdzony rozpoznaniem raka gruczołu krokowego
- •Wcześniejsze leczenie operacyjne lub radioterapia raka ograniczonego do prostaty
- •Widoczne przerzuty w badaniu PET/CT (do 10 zmian, nie więcej niż 4 w kościach)
- •Brak przerzutów do mózgu lub wątroby
- •Wystarczająco dobry ogólny stan zdrowia (ECOG 0-2)
- •Wyniki badań krwi w normie lub bliskie normie
- •Możliwość rozpoczęcia leczenia w ciągu 28 dni od wizyty wstępnej
✗ Disqualifies
- •Brak widocznych zmian nowotworowych w badaniu PET/CT
- •Wcześniejsze podobne leczenie (jeśli trwało dłużej niż 3 miesiące lub przerwano mniej niż 12 miesięcy temu)
- •Przerzuty do mózgu lub wątroby
- •Więcej niż 10 ognisk przerzutów lub więcej niż 4 w kościach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 18, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Mayo Clinic in Rochester
Rochester, United States
Trial contact
Clinical Trials Referral Office
Urology Study Coordinator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/19/2026.
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