AzTrials
AzTrials

Recurrent Prostate AdenocarcinomaPhase 2SPARKLENCT07650240

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

A Phase 2 study testing Abiraterone Acetate, Biospecimen Collection and Leuprolide Acetate in people with Recurrent Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone Acetate, Biospecimen Collection and Leuprolide Acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteUnited States
Study dates
4 Aug 2026to 30 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

Urology Study Coordinator contact

507-422-5076

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Urology Study Coordinator, 507-422-5076

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer

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.

Being tested
Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate, Lutetium Lu 177 Vipivotide Tetraxetan, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone AcetateDrug

    Also called BR9004, BR9004-1, CB 7630, CB-7630

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Leuprolide AcetateDrug

    Also called A 43818, A-43818, A43818, Abbott 43818

    Given SC

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617

    Given IV

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

  • PSMA PET-CT ScanProcedure or surgery

    Also called PET-CT (PSMA), Prostate-specific Membrane Antigen PET-CT, PSMA PET-CT

    Undergo PSMA PET/CT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT

Study groups in NCT07650240
Study groupRoleWhat they receive
Arm A1 (177Lu-PSMA-617, iADT)ExperimentalPatients receive 177Lu-PSMA-617 IV once every 6 weeks and leuprolide acetate subcutaneous (SC) once every 3 months (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.
Receives: Procedure: Biospecimen Collection; Drug: Leuprolide Acetate; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: PSMA PET-CT Scan; Other: Quality-of-Life Assessment; Procedure: Single Photon Emission Computed Tomography
Arm A2 (iADT)Active comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Drug: Leuprolide Acetate; Procedure: PSMA PET-CT Scan; Other: Quality-of-Life Assessment
Arm B1 (177Lu-PSMA-617, iADT, iAA, P)ExperimentalPatients receive 177Lu-PSMA-617 IV every 6 weeks, leuprolide acetate SC Q3M, abiraterone acetate PO (by mouth) QD (once a day) and prednisone PO BID (twice a day). 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.
Receives: Drug: Abiraterone Acetate; Procedure: Biospecimen Collection; Drug: Leuprolide Acetate; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Drug: Prednisone; Procedure: PSMA PET-CT Scan; Other: Quality-of-Life Assessment; Procedure: Single Photon Emission Computed Tomography
Arm B2 (iADT, iAA, P)Active comparatorPatients 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.
Receives: Drug: Abiraterone Acetate; Procedure: Biospecimen Collection; Drug: Leuprolide Acetate; Drug: Prednisone; Procedure: PSMA PET-CT Scan; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic progression free survival (rPFS)

    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.

    Measured: At 18 months

Secondary outcomes (3)

  1. Biochemical recurrence free survival (BCR-FS)

    Assessed using PSMA scans. Defined as the time after treatment during which no signs of biochemical recurrence are found.

    Measured: At 12 months

  2. Treatment-free interval

    Defined as the length of time a patient remains off active systemic therapies while maintaining disease control.

    Measured: Up to 18 months

  3. Overall survival

    Defined as the time from randomization or enrollment to death from any cause, whichever occurs first.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start4 Aug 2026
  3. Primary completion30 Dec 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07650240
Sponsor's protocol ID
MC250507
Other IDs
25-008953, SPARKLE
Acronym
SPARKLE
Status last verified
Sep 2026
First submitted
10 Jun 2026
Last updated
18 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Biospecimen Collection and Leuprolide Acetate in people with Recurrent Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic progression free survival (rPFS) (time frame: At 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07650240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in