A preliminary study of the addition of prazosin to radiotherapy in men with prostate cancer

Phase 1

Active, not recruiting

• Conditions: Cancer - Prostate; Prostate Cancer

• Registration Number: ACTRN12621000784819
• Lead Sponsor: GenesisCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-22
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate
- Age greater or equal to 18 years
- Normal liver function: ALT <2x ULN, Bilirubin <1.5 x ULN or normal conjugated bilirubin
- Normal renal function: Serum urea and creatinine <1.5 ULN
- 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

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
- Has received prior brachytherapy or radiotherapy for PCa to the same site
- Planned treatment with brachytherapy
- Planned treatment with stereotactic ablative body radiotherapy (SABR)
- Pre-existing hypotension defined as: Seated blood pressure < 100 mmHg systolic and/or < 70 mmHg diastolic
- Pre-existing orthostatic hypotension defined as: Decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within three minutes of standing when compared with seated blood pressure
- Allergy to quinazolines
- Treatment with a1-antagonists with the last 6 months: Including all drugs within the class e.g. tamsulosin, silodosin, doxazosin, alfuzosin and prazosin
- Pre-existing cataract disease where cataract surgery is planned during the time that the patient would be receiving prazosin
- Patients are high falls risk as assessed by physician
- Planned cataract surgery
- Concurrent participation in other clinical trials or use of other investigational products
- Known gastrointestinal disease that could affect the absorption or tolerance of the IP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protocol and treatment schedule compliance as a composite outcome. Compliance feasibility will be defined as = 80% compliance rate to the study protocol/treatment schedule. Treatment compliance will be defined as participants missing < 10% of prazosin doses and being able to complete all radiotherapy fractions. Treatment compliance will be assessed using participant dosing diaries and the return of medication packaging and unused tablets. Assessment compliance will be defined as a completion of = 80% required assessments.[ At the completion of radiotherapy and prazosin treatment.]