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NCT04729114 · ClinicalTrials.gov registry record · Phase 1

A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer

A Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Astellas Pharma Global Development.

Recruiting
Registry status
Phase 1
Development phase
174
Enrollment target
20
Study locations

NCT04729114 is a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 174 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT04729114, a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Astellas Pharma Global Development.

RECRUITING
Registry status
Phase 1
Development phase
174 participants
Enrollment target
20
Study locations

Study Summary

Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work. The main aims of the study are: * to check the safety of PRL-02 depot given with and without another medicine called enzalutamide. * to check if the men can tolerate PRL-02 depot given with or without enzalutamide. * to find a suitable dose of PRL-02 depot. This study will be in 2 parts. In the first part, different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines. In the second part of the study, men who have previously taken a hormone therapy called abiraterone acetate or have previously taken 1 specific hormone therapy as part of their prostate cancer treatment can take part. Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks. They will also take dexamethasone or prednisone, or enzalutamide once a day. The other medicines they take depend on which group and which part of the study they are in. During the study, the men will visit the clinic several times for health checks and scans. After the final visit, men whose cancer has not become worse will continue to have health checks and scans every few months.

Conditions Studied

Prostate Cancer Metastatic Castration-Resistant Prostate Cancer Metastatic Castration-Sensitive Prostate Cancer

Interventions

  • DRUG enzalutamide
  • DRUG prednisone
  • DRUG dexamethasone
  • DRUG PRL-02 injection

Study Locations (20)

California

  • Los Angeles Cancer Network - Anaheim
  • Providence Medical Group Oncology Santa Rosa - Santa Rosa

Indiana

  • Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne
  • First Urology - Jeffersonville

Maryland

  • National Cancer Institute - Bethesda
  • Chesapeake Urology - Towson

Ohio

  • Helios Clinical Research, LLC - Middleburg Heights
  • Toledo Clinical Cancer Center - Toledo

Texas

  • Urology Clinics of North Texas - Dallas
  • Houston Metro Urology - Houston

Arizona

  • Arizona Urology Specialists - Tucson

Florida

  • Florida Urology Partners - Tampa

Kansas

  • Wichita Urology Group - Wichita

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2021-06-14
Est. Completion 2029-05-31
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04729114

The ClinicalTrials.gov registry entry for NCT04729114 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which enzalutamide is the first listed.

NCT04729114 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Indiana, Maryland.

Frequently Asked Questions

What is clinical trial NCT04729114 about?

NCT04729114 is a clinical study titled "A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer". Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their canc...

What is the current status of trial NCT04729114?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2021-06-14. Estimated completion is 2029-05-31.

What conditions does trial NCT04729114 study?

This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer.

What interventions are being tested in trial NCT04729114?

The interventions under investigation include: enzalutamide (DRUG), prednisone (DRUG), dexamethasone (DRUG), PRL-02 injection (DRUG).

Who is sponsoring clinical trial NCT04729114?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04729114 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.