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

NCT05689021 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC210503NCI-2022-1079821-010477
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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) 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.

Conditions

Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (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.

  Baseline to end of treatment (approximately 13 months)

Secondary Outcomes (3)

• Radiologic progression-free survival (rPFS)

  Up to 2 years

• Incidence of adverse events

  Up to 30 days after last treatment dose

• Time to progression

  Up to 2 years

Study Arms (1)

Treatment (CJNJ-67652000 and prednisone)

EXPERIMENTAL

Patients receive CJNJ-67652000 PO and prednisone PO on study. Patients also undergo blood specimen collection, CT or MRI, and bone scan throughout the trial.

Drug: Abiraterone Acetate/Niraparib; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Prednisone

Interventions

Abiraterone Acetate/Niraparib DRUG

Given PO

Also known as: Abiraterone Acetate and Niraparib Tosylate Monohydrate, Abiraterone Acetate/Niraparib Tosylate Monohydrate, Akeega, CJNJ-67652000, Niraparib and Abiraterone Acetate, Niraparib Tosylate Monohydrate and Abiraterone Acetate, Niraparib Tosylate Monohydrate/Abiraterone Acetate, Niraparib/Abiraterone Acetate

Treatment (CJNJ-67652000 and prednisone)

Biospecimen Collection PROCEDURE

Undergo blood specimen collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (CJNJ-67652000 and prednisone)

Bone Scan PROCEDURE

Undergo technetium-99m bone scan

Also known as: Bone Scintigraphy

Treatment (CJNJ-67652000 and prednisone)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (CJNJ-67652000 and prednisone)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (CJNJ-67652000 and prednisone)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Treatment (CJNJ-67652000 and prednisone)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male \>= 18 years of age
• Histological confirmation of adenocarcinoma of the prostate
• 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
• 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:

You may not qualify if:

• 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
• 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)
• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; niraparib; Specimen Handling; Magnetic Resonance Spectroscopy; Prednisone; deltacortene; prednylidene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Pregnadienediols; Pregnadienes; Pregnanes

Study Officials

• Daniel S. Childs, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: March 5, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (3)