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Castration-Resistant Prostate CarcinomaPhase 2NCT04754425

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

A Phase 2 study testing Biopsy, Biospecimen Collection and Erdafitinib in people with Castration-Resistant Prostate Carcinoma and Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents, run by M.D. Anderson Cancer Center at 1 site 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 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biopsy, Biospecimen Collection and Erdafitinib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
15 Jul 2021to 2 Feb 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

  • 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)
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  • 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)
  • Serum magnesium >= ILLN
  • Serum albumin >= 3.0 g/dL
  • Serum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert's disease)
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN for patients without liver metastases. For patients with liver metastases AST or ALT < 5 x IULN is allowed
  • Able to swallow study drugs whole as a tablet/capsule
  • Patients must agree to tissue and blood collection for correlative studies at the specified time points
  • Male subject with a female partner of childbearing potential or pregnant must agree to use two acceptable methods of contraception and not to donate sperm from time of screening until 3 months after the last dose of study treatments

Who cannot join

  • 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
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  • 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
  • Corrected QT interval (QTc) prolongation as confirmed by triplicate assessment at screening (Fridericia; QTc > 480 milliseconds)
  • Pulmonary embolism or other venous thromboembolism (VTE) within the preceding 2 months
  • Known active autoimmune deficiency syndrome (AIDS) (human immunodeficiency virus [HIV] infection), unless the subject has been on a stable anti-retroviral therapy regimen for the last 6 months or more, has had no opportunistic infections in the last 6 months, and has CD4 count > 350
  • Known active hepatitis B or C infection (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction ([PCR] test and subjects with hepatitis B with positive hepatitis B surface antibody are allowed)
  • Not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, grade 1 neuropathy, grade 1-2 hearing loss)
  • Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
  • Major surgery within 4 weeks before randomization
  • Untreated symptomatic spinal cord compression

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Study of Erdafitinib in Castration-Resistant Prostate Cancer Patients Evaluating Markers of Bone Remodeling and FGF Signaling in Plasma and Bone Marrow

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate efficacy of erdafitinib in subjects with advanced prostate cancer who have progressed on a second-generation androgen receptor (AR)-targeting agents (SART).

SECONDARY OBJECTIVES:

  1. To evaluate the objective response rate II. To measure Time on Treatment (ToT) as a surrogate of clinical efficacy and Progression-Free Survival (PFS) III. To measure PFS. IV. To correlate bone specific alkaline phosphatase (BAP) modulation with response, ToT and PFS.
  2. To correlate prostate specific antigen (PSA) modulation with response, ToT and PFS.

VI. To characterize the safety profile of subjects treated with erdafitinib. VII. To measure overall survival. VIII. To collect and archive bone marrow biopsies and aspirates, serum and plasma in study patients for later hypothesis generating associations.

EXPLORATORY OBJECTIVE:

  1. To evaluate DNA, ribonucleic acid (RNA), or protein biomarkers in tissue and blood samples which potentially predict tumor response or resistance to erdafitinib.

OUTLINE:

Patients receive erdafitinib orally (PO) once daily (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.

After completion of study treatment, patients are followed up at 30 days, every 16 weeks for 1 year, and then every 6 months thereafter.

Being tested
Biopsy, Biospecimen Collection, Erdafitinib
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of blood and bone marrow

  • ErdafitinibDrug

    Also called Balversa, JNJ-42756493

    Given PO

Study groups in NCT04754425
Study groupRoleWhat they receive
Treatment (erdafitinib, biospecimen collection)ExperimentalPatients 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.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Erdafitinib

What is being measured

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

  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.

    Measured: Up to 5 years

Secondary outcomes (6)

  1. Overall response rate

    Defined as (a) the proportion of subjects with soft tissue disease who achieve complete response or partial response, as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by the investigator and (b) the proportion of subjects with improvement in bone imaging as assessed by the principal investigator. Will be estimated with proportion and its corresponding 95% CI.

    Measured: Up to 5 years

  2. Time on treatment

    Measured as a surrogate of clinical efficacy and progression-free survival (PFS). Will be estimated using the method of Kaplan and Meier and the effects of potential.

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

  3. Progression-free survival

    Will be estimated using the method of Kaplan and Meier and the effects of potential.

    Measured: 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

  4. Prostate specific antigen modulation

    Calculated as the maximal percentage change (decrease versus increase) on treatment.

    Measured: Up to 5 years

  5. Incidence of adverse events

    Will be reported by their National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 term by grade and attribution.

    Measured: Up to 5 years

  6. Overall survival

    Will be estimated using the method of Kaplan and Meier and the effects of potential.

    Measured: Duration in weeks/months from the time of treatment start to the date of death, assessed up to 5 years

Timeline

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

  1. First posted15 Feb 2021
  2. Study start15 Jul 2021
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Why it stopped: \<75% participation

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04754425
Sponsor's protocol ID
2020-0953
Other IDs
NCI-2021-00663, 2020-0953
Status last verified
Feb 2026
First submitted
10 Feb 2021
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy, Biospecimen Collection and Erdafitinib in people with Castration-Resistant Prostate Carcinoma and Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents, run by M.D. Anderson Cancer Center at 1 site 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 22 inclusion and 23 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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: \<75% participation). 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?

Bone specific alkaline phosphatase (BAP) modulation (time frame: Up to 5 years). 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 NCT04754425.

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 6 Feb 2026.

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