Health TrialsbyHealthPanel

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

ConditionsRecurrent Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8Castration-Sensitive Prostate CancerMetastatic Hormone-sensitive Prostate Cancer (mHSPC)Prostate CancerProstate AdenocarcinomaAdenocarcinoma of the ProstateLocalized Prostate CarcinomaMetastatic Prostate CancerMetastatic Prostate AdenocarcinomaAdvanced Prostate CancerAdvanced Prostate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMayo Clinic

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abiraterone Acetate

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Leuprolide Acetate

    Drug

    Given SC

  • Lutetium Lu 177 Vipivotide Tetraxetan

    Drug

    Given IV

  • Prednisone

    Drug

    Given PO

  • PSMA PET-CT Scan

    Procedure/Surgery

    Undergo PSMA PET/CT

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT

Treatment groups

202 Participants
are divided into 4 treatment groups
Group A: Arm A1 (177Lu-PSMA-617, iADT)Experimental treatment 6 interventions
Group B: Arm A2 (iADT)Active comparator 4 interventions
Group C: Arm B1 (177Lu-PSMA-617, iADT, iAA, P)Experimental treatment 8 interventions
Group D: Arm B2 (iADT, iAA, P)Active comparator 6 interventions

Trial outcomes

Primary outcomes

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.

Time frame
At 18 months

Secondary outcomes

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.

Time frame
At 12 months
2

Treatment-free interval

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

Time frame
Up to 18 months
3

Overall survival

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

Time frame
Up to 3 years

Other outcomes

1

Quality of life - FACT-P

Assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, a 39-item questionnaire used to measures Health-Related Quality of Life (HRQOL) in prostate cancer patients. Responses to each question are scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Possible total scores range from 0-156, with higher scores indicating better QoL. A drop in the FACT-P total score \>5 points will be considered clinically meaningful.

Time frame
At baseline and then every 3 months up to 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now