drugset / Trial / NCT03513211

Phase I/II Study of Hydroxychloroquine With Itraconazole With Biochemically Recurrent Prostate Cancer

NCT03513211

Phase 1/2 Completed 12 enrolled St Vincent's Hospital, Sydney
Non-randomizedSequentialOpen-labelTreatment

Summary

Recent pre-clinical work has suggested that Itraconazole has an anti-cancer effect that works synergistically with hydroxychloroquine. This may delay the need for androgen deprivation therapy (ADT) and its associated toxicities in men with biochemically recurrent (BCR) prostate cancer. This study aims to determine feasibility, safety and efficacy of suba-itraconazole (SI) in combination with hydroxychloroquine (HQ) in the treatment of biochemically recurrent (BCR) prostate cancer as means of delaying time to commencement of androgen deprivation therapy.

Timeline

Start
2018-08-23
Primary completion
2023-08-30
Completion
2023-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule
Subject Itraconazole Small molecule 150 mg Oral

Indications