This is a multicentre, phase II, randomized, open label study to evaluate the efficacy and safety of monthly Radium 223 in prolonging the off treatment interval of men with localized prostate cancer receiving intermittent androgen ablation therapy for a rising PSA post-radiation or post-prostatectomy, who are at high risk for occult metastases.
Eligible subjects will be randomized in a 1:1 ratio to receive either (1) study medication, Radium 223 monthly for six months or (2) no treatment (usual care). All patients will have a physical exam, PSA, testosterone and clinical lab tests conducted monthly. Group 1 will receive monthly Radium 233 beginning one month after discontinuing ADT, for a maximum of 6 months of treatment. Radium-223 will be given in accordance with the Canadian product label and Product Monograph at 50kBq/kg. If PSA reaches 5ng/ml before 7 months after discontinuing ADT, the patient will discontinue Radium 223 and resume ADT. Group 2 will have no further therapy until their PSA reaches 5ng/ml, at which point they will resume ADT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Radium 223 Dichloride (Xofigo®) monthly for six months
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
PSA > 5.0ng/ml
Time to PSA \> 5.0ng/ml in the off treatment interval during intermittent androgen ablation therapy, as measured from randomization.
Time frame: Time to PSA > 5.0ng/ml in the off treatment, through study completion at 2 years.
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