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?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000566730

Enrollment

Registered

2013-05-20

Start date

2013-05-17

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

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.

Outcome results