Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer

NCT04754425 | Terminated Phase 2 FDA Drug

• 2 other identifiers: 2020-0953NCI-2021-00663
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effect of erdafitinib in treating patients with prostate cancer that grows and continues to spread despite the surgical removal of the testes or drugs to block androgen production (castration-resistant). Erdafitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erdafitinib may help control disease in patients with castration-resistant prostate cancer. In addition, studying samples of blood, tissue, plasma, and bone marrow from patients with castration-resistant prostate cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Conditions

Castration-Resistant Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Adenocarcinoma; Metastatic Prostate Small Cell Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• Bone specific alkaline phosphatase (BAP) modulation

  Will assess modulation of BAP under the influence of treatment. Calculated as the maximal percentage change (decrease versus increase) on treatment. BAP in blood samples will be used for the primary analysis. Proportion of patients with BAP reduction along with the 95% confidence interval (95% CI) will be estimated.

  Up to 5 years

Secondary Outcomes (6)

• Overall response rate

  Up to 5 years

• Time on treatment

  Duration in weeks/months from the time of treatment start until the patient goes off treatment for any reason, assessed up to 5 years

• Progression-free survival

  Duration in weeks/months from the time of treatment start to the date of disease progression or death, whichever is reported first, assessed up to 5 years

• Prostate specific antigen modulation

  Up to 5 years

• Incidence of adverse events

  Up to 5 years

Study Arms (1)

Treatment (erdafitinib, biospecimen collection)

EXPERIMENTAL

Patients receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may also undergo collection of blood and bone marrow via biopsy and aspirates.

Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Erdafitinib

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (erdafitinib, biospecimen collection)

Biospecimen Collection PROCEDURE

Undergo collection of blood and bone marrow

Treatment (erdafitinib, biospecimen collection)

Erdafitinib DRUG

Given PO

Also known as: Balversa, JNJ-42756493

Treatment (erdafitinib, biospecimen collection)

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• Histologically proven adenocarcinoma or small cell of the prostate with evidence for skeletal metastases on bone scan and/or computed tomography (CT)/positron emission tomography (PET)/magnetic resonance imaging (MRI) scan. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Serum testosterone levels =\< 50 ng/ml and maintenance of castration with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or orchiectomy
• Patients must have documented evidence of progressive disease as defined by any of the following:
• PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least \>= 1.0 ng/mL
• New or increasing non-bone disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria)
• Positive bone scan with 2 or more new lesions (Prostate Cancer Working Group 3 \[PCWG3\])
• Prior treatment with a second-generation AR-targeting agent (e.g. abiraterone acetate, enzalutamide, apalutamide) is required. Patients may have received up to two such agents
• Patients may have received prior treatment with immunotherapies (sipuleucel-T, checkpoint immunotherapies) or bone targeting therapies (radium-223)
• Both chemotherapy-naive and patients previously treated with chemotherapy are eligible. Chemotherapy pretreated patients may have received a maximum of two prior systemic cytotoxic chemotherapies completed at least 3 weeks prior to initiation of study treatment
• Hemoglobin \>= 8.0 g/dL
• Platelet count \>= 75,000/uL
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• Calculated creatinine clearance (Cockcroft-Gault Equation) \>= 40 mL/min
• Serum potassium \>= institutional lower limit of normal (ILLN)

You may not qualify if:

• Radiation therapy to primary tumor or metastatic sites within 2 weeks of cycle 1, day 1
• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
• A malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 1 year, or has a \>= 30% probability of recurrence within 24 months (except for non-melanoma skin cancer or Ta urothelial carcinomas)
• Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 160 or diastolic pressures above 100 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (For example doctor's visit related stress i.e. "white coat syndrome")
• Eye conditions likely to increase the risk of eye toxicity including
• Corneal or retinal abnormality likely to increase the risk of eye toxicity, or lens conditions such as: untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test
• History of central serous retinopathy (CSR) or retinal vascular occlusion (RVO)
• Active wet, age-related macular degeneration (AMD)
• Diabetic retinopathy with macular edema (non-proliferative)
• Uncontrolled glaucoma (per local standard of care)
• Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
• Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events
• History of uncontrolled cardiovascular disease including:
• Unstable angina, myocardial infarction, ventricular fibrillation, Torsades de Pointes, cardiac arrest, or known congestive heart failure class III-V within the preceding 3 months; cerebrovascular accident or transient ischemic attack within the preceding 3 months
• Mobitz II second degree heart block or third degree heart block

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; erdafitinib

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)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul Corn

  M.D. Anderson Cancer Center

  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: February 10, 2021
• First Posted: February 15, 2021
• Study Start: July 15, 2021
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)