Study of radium-223 dichloride vs standard (NAH) in mCRPC
Research type
Research Study
Full title
A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer progressing on/after one line of NAH.
IRAS ID
280793
Contact name
Hilary Glen
Contact email
Eudract number
2019-000476-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 12 days
Research summary
This study will further assess the safety and efficacy of radium-223 dichloride vs. novel anti-hormonal therapy (NAH) in participants with bone dominant mCRPC progressing on/after one line of NAH.
About 900 participants will take part in the study. Patients will visit the hospital every 2 weeks for the first 6 cycles. From cycle 7 and onwards, patients will visit the hospital on the first day of each cycle only. It is expected that the duration of the study is 2 years. However, this may be longer based on how well they respond to treatment.
Total duration of the Screening period is 28 days. For the radium-223 dichloride arm (Arm A), the total duration of one cycle is 28 days and the total duration of radium-223 dichloride treatment is 6 cycles or until progressive disease (PD), death, or withdrawal of consent, whichever occurs first.
Participants treated with abiraterone acetate plus predniso(lo)ne or enzalutamide (Arm B) will be administered until Progressive disease (PD), death, or withdrawal of consent, whichever occurs first.Participants will be randomized in a 1:1 ratio to radium-223 dichloride or NAH (either AAP or enzalutamide):
Participants will be randomized 1:1 to receive either Arm A (radium-223 dichloride) or Arm B (NAH, either AAP or enzalutamide)
Participants randomized to Arm A will be dosed per label, with 55 kBq/kg of body weight intravenously every 4 weeks up to a maximum of 6 administrations or until Progressive disease (PD), death or withdrawal of consent (whichever occurs first).
Participants randomized to Arm B will be dosed per label, receiving either AAP (1,000 mg) plus 10 mg prednisone or prednisolone*) or enzalutamide (160 mg) continuously on a once daily schedule for 4-weeks intervals until Progressive disease (PD), death, or withdrawal of consent, whichever occurs first.
Participants will be followed up to 30 days (+ 7 days) after the last treatment.
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0219
Date of REC Opinion
5 Nov 2020
REC opinion
Further Information Favourable Opinion