RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests leuprolide alone against leuprolide plus 177Lu-PSMA-617, a drug that sends radiation to prostate cancer cells, with or without abiraterone and prednisone. It is for men with prostate cancer that still responds to hormone treatment and has spread to a limited number of places, either at diagnosis or after coming back.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older who sign a form agreeing to take part.
  • Prostate cancer confirmed by a tissue sample, with prior surgery to remove the prostate or radiation for cancer that had not spread.
  • Cancer must respond to hormone treatment and show enough PSMA, a protein on cancer cells, on a special PET/CT scan.
  • No more than 10 spots where cancer has spread, including no more than 4 bone spots. No spread to the brain or liver. Lymph nodes and total cancer size must meet study limits.
  • Able to care for yourself and be out of bed or a chair for at least half the day.
  • Blood cell counts and liver and kidney test results must meet study limits.
  • Able to start treatment within 28 days of screening and expected to live more than 6 months.
  • Earlier hormone treatment or chemotherapy may be allowed. The listing gives conflicting rules about treatment length; the study team must confirm eligibility.

Who can't join

  • Rising PSA, a blood marker for prostate cancer, without cancer showing on the PSMA scan; or certain cancer spots that do not show enough PSMA.
  • Cancer that has returned in the treated prostate area, or cancer in the spine pressing on the spinal cord.
  • Cancer that grew during treatment to lower male hormones.
  • Hormone treatment or chemotherapy within 12 months before joining.
  • Severe dry mouth, or a history of low blood cell production or kidney disease that could make taking part unsafe.
  • Another cancer that may affect lifespan or study results. Some past, fully treated skin or surface bladder cancers are allowed.
  • Expected to live less than 6 months, or another serious illness that could prevent taking part.
  • Not able to follow the birth control rule: men with partners who could become pregnant must use an accepted method during the study and for 14 weeks after the last 177Lu-PSMA-617 dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

MN