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Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

NCT03511196 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-04

No results posted yet for this study

Summary

Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).

Conditions

Interventions

DRUG

Adaptive Androgen Deprivation Therapy (ADT)

ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.

DRUG

Abiraterone

Prednisone 5 mg once a day with food.

DRUG

Prednisone

Abiraterone 1000 mg daily with empty stomach.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jingsong Zhang, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2022-06-22
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511196 on ClinicalTrials.gov