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RECRUITING Phase 2

Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

NCT04363164 · View on ClinicalTrials.gov ↗

Study Summary

Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.

Interventions

  • DRUG Testosterone cypionate
  • DRUG Enzalutamide
  • DRUG Testosterone enanthate

Study Locations (6)

California

  • University of California, San Diego (UCSD) — San Diego

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore

Massachusetts

  • Dana-Faber Cancer Institute — Boston

Minnesota

  • University of Minnesota — Minneapolis

Nebraska

  • University of Nebraska Medical Center — Omaha

Washington

  • University of Washington/Fred Hutchinson Cancer Center — Seattle

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2020-08-19
Est. Completion 2027-07
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04363164

The ClinicalTrials.gov registry entry for NCT04363164 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Castration Resistant Metastatic Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Testosterone cypionate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04363164 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Maryland, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04363164 about?

NCT04363164 is a clinical study titled "Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression". Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objective...

What is the current status of trial NCT04363164?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2020-08-19. Estimated completion is 2027-07.

What conditions does trial NCT04363164 study?

This clinical trial studies the following conditions: Castration Resistant Metastatic Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04363164?

The interventions under investigation include: Testosterone cypionate (DRUG), Enzalutamide (DRUG), Testosterone enanthate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04363164?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04363164 being conducted?

This trial has 6 study locations across California, Maryland, Massachusetts, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial