NCT03511196

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

A Phase 1b Study of Adaptive Androgen Deprivation Therapy for State IV Castration Sensitive Prostate Cancer

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Investigators proposed this pilot feasibility study to use prostate specific antigen (PSA) response and testosterone level to guide the treatment with androgen deprivation therapy (ADT) \[Leuprolide, Goserelin, and Triptorelin are the most commonly used GnRH agonists for ADT\] and/or abiraterone plus prednisone. Adaptive therapy is a program of chemotherapy where the type and dosage of drug changes in an attempt to kill more of the cancer. Abiraterone acetate with prednisone is a standard of care treatment for mCRPC (metastatic castration resistant prostate cancer). It works by interrupting the male hormone (androgen) making process in the testes, adrenal glands, and tumors. This helps to prevent the growth of tumors that need these hormones to grow.

Conditions

• Prostate Cancer
• Stage IV Prostate Cancer
• Advanced Prostate Cancer
• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-17
• Primary completion: 2022-06-22
• Completion: 2026-09-01
• First posted: 2018-04-27
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study