Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

Phase 0 Active not recruiting 17 enrolled H. Lee Moffitt Cancer Center and Research Institute

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2018-09-17
Primary completion: 2022-06-22
Completion: 2026-09

Outcome

Met primary endpoint

paper the study succeeded in its primary objective of feasibility. PMID 36358643 ↗

Publications

Results Zhang J, Gallaher J, Cunningham JJ, Choi JW, Ionescu F, Chatwal MS, Jain R, Kim Y, Wang L, Brown JS, Anderson AR, Gatenby RA. A Phase 1b Adaptive Androgen Deprivation Therapy Trial in Metastatic Castration Sensitive Prostate Cancer. Cancers (Basel). 2022 Oct 25;14(21):5225. doi: 10.3390/cancers14215225.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	1000 mg	—
Subject	Goserelin	Other / unclassified	—	—
Subject	Leuprolide	Other / unclassified	—	—
Subject	Triptorelin	Other / unclassified	—	—
Background	Prednisone	Other / unclassified	5 mg	—