A Double Blind, Randomised, Dose Finding, Repeat Dose, Phase II, Multicentre Study of Alpharadin® for the Treatment of Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases

Bayer0 sites122 target enrollmentMay 2006

ConditionsProstate Cancer Neoplasm Metastasis

InterventionsRadium-223 dichloride (BAY88-8223)

DrugsRadium-223 dichloride (BAY88-8223)

Overview

Phase: Phase 2
Intervention: Radium-223 dichloride (BAY88-8223)
Conditions: Prostate Cancer
Sponsor: Bayer
Enrollment: 122
Primary Endpoint: Proportion of participants in each dose group with a confirmed PSA response
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

December 2009

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the prostate.
•Hormone refractory with evidence of rising PSA:
•Patient must be maintained on androgen ablation therapy with LHRH agonist (stable dose for at least 8 weeks prior to study entry), or have undergone orchiectomy
•Serum testosterone level is required to be ≤ 50 ng/dl
•Patients who have received prior hormonal drug therapy:
•Flutamide, nilutamide or cyproterone acetate must have stopped at least four weeks prior to study drug administration and progression must have been demonstrated since cessation;
•Bicalutamide must have stopped at least six weeks prior to study drug administration and progression must have been demonstrated since cessation
•Elevated and rising PSA:
•Baseline PSA level ≥ 10 ng/ml
•Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur a minimum of 1 week from the reference value (measure

Exclusion Criteria

•Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
•Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
•More than one regimen of previous cytotoxic chemotherapy
•Has received prior hemibody external radiotherapy
•Has a need for immediate external radiotherapy
•Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
•Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for ≥ 12 weeks before administration of study drug.
•Patients who are ≤ 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
•Patients who have started or stopped systemic steroids, within a week prior to study drug administration
•Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases

Arms & Interventions

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1

25 kBq/kg b.w., 3 times at 6 week intervals

Intervention: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 2

50 kBq/kg b.w., 3 times at 6 week intervals

Intervention: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 3

80 kBq/kg b.w., 3 times at 6 week intervals

Intervention: Radium-223 dichloride (BAY88-8223)

Outcomes

Primary Outcomes

Proportion of participants in each dose group with a confirmed PSA response

Time Frame: 24 weeks, 12 months, 24 months

PSA response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response:a decrease from baseline of at least 50% maintained for at least three weeks.

Secondary Outcomes

Pain Assessment and analgesic consumption(24 weeks, 12 months, 24months)
The maximum percent decrease in PSA level compared to baseline(24 weeks, 12 months, 24 months)
Time to PSA Progression(24 weeks, 12 months, 24 months)
Bone-ALP response (classified as for PSA response) and decrease in bone-ALP level compared to baseline(24 weeks, 12 months, 24 months)
Total number of SRE per patient(24 weeks, 12 months, 24months)
Time to death from first treatment(24 weeks, 12 months, 24months)
Time to Skeletal Related Events (SRE)(24 weeks, 12 months, 24 months)
Adverse events, blood chemistry and haematological toxicity(24 weeks, 12 months, 24 months)