NCT02656563

Radium 223 Following Intermittent ADT

Phase II, Randomized, Open Label to Evaluate Efficacy,Safety of Radium 223 in Prolonging the Off Treatment Interval in Men With Rising PSA Post-rad, or Post-prostatectomy Without Bone Mets on Intermittent Androgen Ablation Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Canadian Urology Research Consortium · Academic / Other
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radium 223 Dichloride (Xofigo®)	Radium 223 Dichloride (Xofigo®) monthly for six months

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-01-15
• Last updated: 2016-10-14

Locations

1 site across 1 country: Canada