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Castration-Resistant Prostate CarcinomaPhase 2NCT05689021

CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations

A Phase 2 study testing Abiraterone Acetate/Niraparib, Biospecimen Collection and Bone Scan in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by Mayo Clinic at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic)… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone Acetate/Niraparib, Biospecimen Collection and Bone Scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesUnited States
Study dates
5 Mar 2024to 2 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 >= 18 years of age
  • Histological confirmation of adenocarcinoma of the prostate
  • Qualifying deleterious SPOP mutation detected on any archival genomic assay (tissue and/or liquid biopsy) is acceptable for study inclusion. Qualifying mutation(s) of SPOP include any genomic change predicted to be deleterious or suspected deleterious. SPOP status must be established prior to involvement on the trial
  • Evidence of metastatic castration-resistant prostate cancer, defined as at least one (1) documented metastatic lesion on either bone scan or CT scan. Bone only disease is acceptable for enrollment. Non-bone metastatic lesions must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Subjects whose disease spread is limited to regional pelvic lymph nodes or local recurrence (e.g. bladder, rectum) are not eligible
  • Radiographic or PSA progression while on androgen deprivation therapy (or after bilateral orchiectomy) AND at least one prior AR-targeted therapy (abiraterone acetate, enzalutamide, apalutamide, darolutamide or investigational AR-targeted agents). PSA progression is a PSA increase that is >= 25% and >= 2 ng/mL above the nadir, and which is confirmed by a second value (minimum 1 week interval between tests). For radiographic progression of soft tissue lesions, modified RECIST 1.1 criteria will be used to qualify entry. For radiographic progression of bony disease, two new lesions must be seen as per PCWG3 criteria. No confirmatory scan of bone progression is required prior to study entry
  • A maximum of two lines of prior taxane (docetaxel and/or cabazitaxel) chemotherapy will be allowed, but are not required
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Surgically or medically castrated, with serum testosterone levels of =< 50 ng/dL (1.73 nM). For patients currently being treated with luteinizing hormone-releasing hormone (LHRH) analogs (ie, patients who have not undergone an orchiectomy), therapy must be continued throughout the study
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (within 14 days prior to registration)
  • Platelet count >= 100,000/mm^3 (within 14 days prior to registration)
  • Hemoglobin >= 10 g/dL independent of transfusion within 14 days
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =< 1.5 x ULN, subject may be eligible as determined by the medical monitor) (within 14 days prior to registration)
  • Alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration)
  • Aspartate transaminase (AST) =< 3 x ULN (within 14 days prior to registration)
  • Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (within 14 days prior to registration)
  • Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) for the time period specified:
  • Use a condom during sex while being treated and for 120 days after the last dose of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination)
  • Do not make semen donations during treatment and for 120 days after the last dose of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination)
  • Those with female partners of childbearing potential may be enrolled if they are:
  • Documented to be surgically sterile (ie, vasectomy);
  • Committed to practicing true abstinence during treatment and for 120 days after the last CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) dose; or
  • Committed to using an effective method of contraception with their partner during treatment and for 120 days following the last dose of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination)
  • Provide written informed consent

Who cannot join

  • Prior treatment with PARP inhibitor or platinum chemotherapy
  • Historical or current diagnosis of myelodysplastic syndrome or myeloid malignancy
  • Any of the following prior therapies:
  • Surgery =< 3 weeks prior to registration
  • Chemotherapy =< 2 weeks prior to registration
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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  • Clinician assessed prognosis of less than 16 weeks
  • Human immunodeficiency virus (HIV) positive subjects with 1 or more of the following:
  • Not receiving highly active antiretroviral therapy
  • Receiving antiretroviral therapy that may interfere with the study drug (consult the sponsor for review of medication prior to enrollment)
  • A change in antiretroviral therapy within 6 months of the start of screening (except if, after consultation with the sponsor-investigator on exclusion criterion, a change is made to avoid a potential drug-drug interaction with the study drug)
  • CD4 count < 350 at screening
  • An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure (left ventricular ejection fraction [LVEF] < 50% or New York Heart Association [NYHA] class III or IV heart failure)
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Myocardial infarction within the last 6 months
  • Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure [BP] >= 95 mmHg). Subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
  • Or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 3 years prior to registration
  • EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or malignancy not expected to require therapy (systemic or radiation) in the next 1 year
  • History of myocardial infarction =< 6 months
  • Symptomatic brain metastases
  • Current evidence of any of the following:
  • Any medical condition that would make prednisone use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone (or equivalent once daily

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Phase 2 Study of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With or Without Homologous Recombination Deficiency

This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. 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 CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the efficacy of abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone as assessed by prostate-specific antigen decline >= 50% (PSA50) response rate in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed prior treatment with androgen receptor (AR)-targeted therapy and have a qualifying, deleterious SPOP mutation.

SECONDARY OBJECTIVES:

  1. To assess the radiologic progression free survival (rPFS) of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) and prednisone treatment in patients with mCRPC who have failed prior treatment with AR-targeted therapy and have a qualifying, deleterious SPOP mutation.

II. To assess best radiographic response using Prostate Cancer Working Group 3 (PCWG3) criteria.

III. To assess time to prostate specific antigen (PSA) progression. IV. To assess safety and tolerability using National Cancer Institute (NCI) Common Toxicity Criteria Version 5.0.

CORRELATIVE RESEARCH OBJECTIVES:

  1. To explore the landscape of genomic alterations occurring after use of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) and prednisone.

II. To use blood, tissue, or organoid lines for identifying predictive biomarkers of response, investigating drug resistance mechanisms, and for future drug efficacy studies.

III. To explore the relationship of other genomic alterations in the tumor tissue with overall response rate (ORR) and disease progression.

OUTLINE:

Patients receive CJNJ-67652000 orally (PO) and prednisone PO on study. Patients also undergo blood specimen collection, computed tomography (CT) or magnetic resonance imaging (MRI), and bone scan throughout the trial.

Being tested
Abiraterone Acetate/Niraparib, Biospecimen Collection, Bone Scan, Computed Tomography, Magnetic Resonance Imaging
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 Acetate/NiraparibDrug

    Also called Abiraterone Acetate and Niraparib Tosylate Monohydrate, Abiraterone Acetate/Niraparib Tosylate Monohydrate, Akeega, CJNJ-67652000

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood specimen collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo technetium-99m bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo MRI

  • PrednisoneDrug

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

    Given PO

Study groups in NCT05689021
Study groupRoleWhat they receive
Treatment (CJNJ-67652000 and prednisone)ExperimentalPatients receive CJNJ-67652000 PO and prednisone PO on study. Patients also undergo blood specimen collection, CT or MRI, and bone scan throughout the trial.
Receives: Drug: Abiraterone Acetate/Niraparib; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Prednisone

What is being measured

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

  1. Prostate specific antigen (PSA) response rate (PSA decline by >= 50% [PSA50])

    PSA50 response rate is defined as > 50% PSA decrease as compared to baseline. The proportion of PSA responses will be estimated by the number of PSA responses divided by the total number of evaluable patients. 95% exact binomial confidence intervals will be computed. The frequency and relative frequency of individual PSA response categories will also be computed. In addition, the maximum percentage change for PSA will be computed and displayed graphically via waterfall plots for individual patients.

    Measured: Baseline to end of treatment (approximately 13 months)

Secondary outcomes (3)

  1. Radiologic progression-free survival (rPFS)

    Defined as the time from registration until radiologic progression or death due to any cause The distribution of survival time will be estimated using the method of Kaplan-Meier. In addition, the proportional hazards model will be applied to assess rPFS while adjusting for important baseline covariates.

    Measured: Up to 2 years

  2. Incidence of adverse events

    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

    Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence interval.

    Measured: Up to 30 days after last treatment dose

  3. Time to progression

    Defined as the time from registration to the earliest date of documentation of progression. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

    Measured: Up to 2 years

Timeline

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

  1. First posted18 Jan 2023
  2. Study start5 Mar 2024
  3. Primary completion2 Jul 2026
  4. Study completion2 Jul 2026

Why it stopped: Sponsor decided to close due to slow accrual and lack of efficacy

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05689021
Sponsor's protocol ID
MC210503
Other IDs
21-010477
Status last verified
Jul 2026
First submitted
9 Jan 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
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/Niraparib, Biospecimen Collection and Bone Scan in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by Mayo Clinic at 3 sites 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 29 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: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study was stopped early (reason given: Sponsor decided to close due to slow accrual and lack of efficacy). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate specific antigen (PSA) response rate (PSA decline by >= 50% [PSA50]) (time frame: Baseline to end of treatment (approximately 13 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 NCT05689021.

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 22 Jul 2026.

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