RecruitingACTRN12613000566730

Natural Course of Hot Flash Symptoms in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer – a Pilot Investigation.

In men receiving androgen-deprivation therapy for histologically confirmed prostate cancer, what is the natural course of hot flash symptoms?

Sponsor

A/Professor Henry Woo

Enrollment

20 participants

Start Date

May 17, 2013

Study Type

Observational

Conditions

Natural course of hot flashes in men with prostate cancer, receiving ADT for the first time.

Summary

This study is observing the natural course of hot flash symptoms in men receiving androgen deprivation therapy (ADT) in the form of luteinizing hormone releasing hormone (LHRH) analogues for histologically confirmed hormone-naive prostate cancer. Who is it for? You may be eligible to join this study if you are a male with histologically confirmed and hormone-naive prostate cancer and have commenced on ADT in the form of LHRH analogues for the first time. Trial details In this study, you will be observed for a total period of 3 years. You will be required to complete a validated questionnaire called the Hot Flash Score. This will need to be completed at 1, 2, 3, 6, 9 and 12 months following commencement of ADT. Thereafter, you will be required to complete the Hot Flash Score questionnaire every 6 months until the completion of the study at 3 years. All other treatment and investigations will be carried out according to standard care – that is, no additional pathology tests will be undertaken compared to men who would otherwise not be enrolled in this study.

Eligibility

Sex: Males

Plain Language Summary

Simplified for easier understanding

This study is observing how hot flashes naturally develop and change over time in men being treated for prostate cancer with hormone therapy (androgen deprivation therapy, or ADT). Hot flashes are a very common side effect of this treatment and can significantly affect quality of life. Participants will fill out a hot flash questionnaire at regular intervals over 3 years. No extra tests or treatments are needed beyond what is already part of their usual cancer care. You may be eligible if: - You are a male with prostate cancer that has been confirmed by biopsy - Your cancer has not previously been treated with hormone therapy - You are starting androgen deprivation therapy (LHRH analogues) for the first time - You are able to complete the questionnaire independently You may NOT be eligible if: - You have previously received androgen deprivation therapy - You are unable to complete the hot flash questionnaire on your own - Your ECOG performance status is 2 or higher (significant limitations in daily activity) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This pilot study will prospectively follow a cohort of 20 men with hormone naive prostate cancer who have been commenced on ADT in the form of LHRH analogues. This study will be conducted over a total of three years. Participants will be asked to complete a Hot Flash Score form. The Hot Flash Score will be measured at 1, 2 and 3 months following the initiation of androgen-deprivation therapy, and then every 3 months for total twelve-month period. Hot Flash score forms will be completed 6-monthly thereafter, for the remainder of the observation period. In addition to the Hot Flash Score, patients will have their baseline and progression testosterone and Prostate Specific Antigen (PSA) levels measured as part of their standard of care. No additional pathology tests will be undertaken compared to men who would otherwise not be enrolled in this study.

Locations(1)

NSW, Australia

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ACTRN12613000566730