None listed
Conditions
Brief summary
This study compares the safety and efficacy of two different treatment strategies (active surveillance with selective intervention versus radical treatment) in patients with favourable risk prostate cancer. Who is it for? You can join this study if you have been recently diagnosed with favourable risk prostate cancer and are a suitable candidate for radical prostatectomy or radiotherapy. Trial Details: Participants in this study will be randomly allocated to one of two treatment groups. Patients allocated to Group 1 will undergo either radical prostatectomy or radiotherapy based on you and your treating doctor’s preferences. Patients allocated to Group 2 will not undergo any immediate treatment. Rather, a ‘watchful waiting’ approach will be taken whereby your cancer is monitored closely and treatment (surgery or radiotherapy) is only undertaken if progression occurs. The results of this study will be useful to help guide patients and physicians in choosing the best treatment strategies to manage their cancer.
Interventions
Arm 1:
Radical intervention (radical prostatectomy or radiotherapy based on patient and physician preference) within 90 days of randomisation.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must fulfil all of the following criteria to be eligible for admission to the study: * Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization. & Patient has been classified as favourable risk as defined by the following: * Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis; Clinical (diagnostic biopsy) Gleason sum < 7; PSA < 10.0 ng/ml (ug/L) Note: patients who have received prior treatment with 5-alpha reductase inhibitors (5ARI) must adhere to the following criteria: * < 2 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 10.0 (ng/ml or ug/L) to be eligible. * 2-6 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 7.0 (ng/ml or ug/L) to be eligible. * > 6 months months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 5.0 (ng/ml or ug/L) to be eligible. * Physical examination, rectal examination and transrectal ultrasound have been done within 6 months prior to randomization and radiographic studies, if indicated, are negative for metastasis. * Patient is a suitable candidate for radical prostatectomy or radiotherapy. * No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, and androgen deprivation therapy for greater than 3 months. * ECOG Performance Status 0, 1 or 2. * Patient has a minimum life expectancy of > 10 years. * The patient is willing to complete the quality of life questionnaires in English unless unable due to illiteracy in English, loss of sight, or other equivalent reason. * Patient consent has been obtained according to local Institutional and/or University Human Experimentation Committee requirements. * Patient is accessible for treatment and follow-up. * Protocol treatment is to begin within 90 days of randomisation.
Exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to the study: * History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for > 5 years from randomisation. * Planned androgen therapy except in the context of radical therapy.
Outcome results
None listed