atural Course of Hot Flash Symptoms in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer – a Pilot Investigation.
Not Applicable
Recruiting
- Conditions
- atural course of hot flashes in men with prostate cancer, receiving ADT for the first time.Natural course of hot flashes in men with prostate cancer, receiving ADT for the first time.Cancer - Prostate
- Registration Number
- ACTRN12613000566730
- Lead Sponsor
- A/Professor Henry Woo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
Men with histologically confirmed and hormone-naive prostate cancer, being commence on androgen-deprivation therapy for the first time.
Exclusion Criteria
Exclusion criteria include previous androgen-deprivation therapy, participant inability to complete a hot flash score independently, and an ECOG status of 2 or more.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objectives of this study is to determine the natural course of hot flash symptoms in men with receiving ADT for histologically confirmed, hormone-naive prostate cancer. <br><br>Men will complete a validated questionnaire called the Hot Flash Score. This will be completed at 1, 2, 3, 6, 9 and 12 months following the commencement of ADT. Thereafter, it will be carried out on a 6 monthly basis until completion of the study at 3 years.[The study cohort will be followed for a total of three years. The suggested clinical observation period is monthly for the first three months, three-monthly for the first year, and six-monthly thereafter, until the total three-year observation period concludes.]
- Secondary Outcome Measures
Name Time Method 1.To measure the frequency and severity of hot flash symptoms in men receiving ADT using a validated hot flash instrument.<br><br>[The Hot Flash Score will be measured at 1, 2 and 3 months following commencement of ADT and every thereafter 3 months until 12 months following commencement of ADT. For the remainder of the observation period, the Hot Flash Score will be completed every 6 months.];2.To record any impact that testosterone and PSA levels may have on recorded hot flashes.[Testosterone will be measured at 3 and 12 months. PSA will be measured at three months, and then every three months thereafter for the first twelve months. PSA will be measured six-monthly thereafter, until the end of the three year observation period. <br>]