None listed
Conditions
Brief summary
1.1 To identify the variation in health related quality of life (HQOL) of patients with advanced prostate cancer treated with intermittent maximal androgen blockade therapy (IMAB). 1.2 To observe the effects of intermittent androgen blockade therapy on the rate and extent of androgen dependent physiological parameters as well as noting serial side effects and patient compliance with the treatment program. 1.3 To gain information regarding time to disease progression and overall survival of patients with advanced prostate cancer treated with intermittent maximal androgen blockade therapy. 1.4 To quantify the relative and absolute amounts of time achieved off treatment from the commencement of active therapy
Interventions
Intermittant androgen suppression. Flutamide (Eulexin) 250 mg three times a day and Leuprolide (Lucrin) 22.5 mg three monthly depot for 9 months (this is the treatment phase), at which point patients cease therapy and remain off therapy providing prostate specific antigen (PSA) < 4 ng/mL. Further androgen suppression treatment as above recommenced when the PSA exceeded 20 ng/mL or greater than pretreatment PSA if that was lower.
Sponsors
Abbott pharmaceuticals Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Prostate cancer requiring commencement of androgen suppression, and likely to be a candidate for an intermittant program.
Exclusion criteria
Prior treatment with hormonal therapy, chemotherapy or biologic response modifiers (other than neoadjuvant hormonal therapy that meets the criteria of 3.1.(i) b) Patients presenting with acute or impending cord compression. c) Patients with extensive involvement manifest by a report of ‘superscan’ type uptake pattern. d) History of prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, or other cancer for which the patient has been disease-free for at least 5 years. e) Patients with known history of hypersensitivity reaction to either study medication or drugs with a similar structure.
Outcome results
None listed