A feasibility study of the repurposing of prazosin to improve treatment outcomes in men receiving radiotherapy for prostate cancer (MiniRaP-00).
The purpose of this study is determine whether it is possible to use a drug called prazosin when men are undergoing radiotherapy for the treatment of prostate cancer.
All participants in this study will be asked to take prazosin two times day starting the week before and until the completion of their radiotherapy treatment for prostate cancer. The dose of medication provided will increase week by week until the final week.
Participants will be monitored throughout the treatment period to determine if they are willing to take the medication alongside their radiation, and followed for 9 months for any side effects.
It is hoped that this study will help determine if it is possible to use prazosin while participants are completing radiotherapy, and help guide the development of a large scale clinical trial which will be used to investigate the efficacy of prazosin combined with radiotherapy.
Key inclusion criteria:
Histologically confirmed adenocarcinoma of the prostate
- Age greater or equal to 18 years
- Normal bone marrow function: Hb greater than or equal to 100 g/L, WCC greater than or equal to 4.0 x 109 cells/L, Platelets greater than or equal to 100 x 10^9 cells/L
- Normal liver function: ALT <2x ULN, Bilirubin <1.5 x ULN or normal conjugated bilirubin
- Normal renal function: Calculated creatinine clearance >40 mL/min using Cockcroft-Gault formula
- ECOG performance status of 0-1
- Participants capable of childbearing only if using adequate contraception
- Willingness to comply with all study procedures including IP administration protocol and required testing
- Signed, written and informed consent
- Participants are available for follow up
Key exclusion criteria:
- Evidence of >5 metastatic sites: Suspected or confirmed by appropriate imaging.
- Under the age of 18 years
- Presence of any medical, psychological or social condition that may hinder compliance
- Use of hormonal therapy more than 30 days prior to commencement of prazosin, other than ADT prescribed for the treatment of PCa
- History of any other previous malignancy within 5 years of the commencement of prazosin, other than successfully treated squamous cell or basal cell carcinoma of the skin
- Previous bilateral orchidectomy
- Has received prior brachytherapy or radiotherapy for PCa to the same