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SPARKLE Trial: Prostate Cancer Treatment Study

This study, called the SPARKLE Trial, is looking at new ways to treat prostate cancer that has spread to a limited number of areas (low-volume metastatic) or has returned after treatment. It compares leuprolide acetate alone to leuprolide acetate combined with Lutetium Lu 177 Vipivotide Tetraxetan, with or without abiraterone acetate and prednisone. Leuprolide acetate is a type of hormone therapy that helps stop the growth of prostate cancer cells by reducing testosterone. The study is open to men aged 18 or older with prostate adenocarcinoma who have had prior treatment for localized disease. The main goal is to see how long patients live without their cancer getting worse on imaging scans (radiographic progression-free survival) at 18 months. The current recruitment status is unclear, and the study plans to enroll 202 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 202 male participants.
What's involved
You would undergo blood sample collections. The specific number of visits or duration of treatment is not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, radiographic progression-free survival, is measured at 18 months, suggesting follow-up for at least this duration.

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NCT07650240

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~202 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Abiraterone AcetateBiospecimen CollectionLeuprolide AcetateLutetium Lu 177 Vipivotide TetraxetanPrednisonePSMA PET-CT Scan

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic progression free survival (rPFS)
Measured over At 18 months

Conditions

Recurrent Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
Castration-Sensitive Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Prostate Cancer
Prostate Adenocarcinoma
Adenocarcinoma of the Prostate
Localized Prostate Carcinoma
Metastatic Prostate Cancer
Metastatic Prostate Adenocarcinoma
Advanced Prostate Cancer
Advanced Prostate Adenocarcinoma

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Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Matthew K. Tollefson, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 detected on PSMA PET/CT scan \[PSMA-avid low volume metastasis (LVM)\]. Patients with standardized uptake value maximum (SUVMax) lesion/liver \>1 \[molecular imaging PSMA (miPSMA) score of 2\] or lesion/parotid \> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET/CT image acquisition and reconstruction
Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET/CT is defined as:
=\< 10 total metastatic spots
Lymph nodes with short axis of =\< 2.5 cm
Total tumor volume (TTV) \< 200 mL
=\< 4 bone metastases
No brain or liver metastases
Eastern Cooperative Oncology Group (ECOG) performance 0 - 2
Hemoglobin \>= 9 g/dL
Platelet count \>= 100,000/mm\^3
Absolute neutrophil count \>= 1,500/mm\^3
Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 2.5 x ULN
Serum creatinine =\< 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \>= 50 mL/min/1.73m\^2
Able to start therapy within 28 days of screening
Expected life expectancy \> 6 months

Exclusion

PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET/CT imaging
PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \>= 1 cm, and bone metastases with a measurable soft tissue component \>= 1 cm
Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)
Patient with spinal metastatic disease-causing cord compression
Patient with prior disease progression on ADT \[castration resistance prostate cancer (CRPC)\]
Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial
Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment
Patients with severe \[Common Terminology Criteria for Adverse Events (CTCAE) grade \> 2\] xerostomia
Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice
Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible
Estimated life expectancy \< 6 months
Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study
Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617

What this trial measures

  • Radiographic progression free survival (rPFS)At 18 months

    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.