Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatment radium-223 dichloride (xofigo, bay88-8223)
Phase phase 2
Sponsor Bayer
Start date March 2014
End date January 2017
Trial size 370 participants
Trial identifier NCT02023697, 16507, 2013-003118-42

Summary

This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update).
radium-223 dichloride (xofigo, bay88-8223)
(Experimental)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 80 kBq/kg body weight (88 kBq/kg after implementation of NIST update).
radium-223 dichloride (xofigo, bay88-8223)
(Experimental)
One injection to be administered every 4 weeks up to 12 injections. The dose per injection is 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update).
radium-223 dichloride (xofigo, bay88-8223)

Primary Outcomes

Measure
Symptomatic skeletal event-free survival
time frame: From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-up

Secondary Outcomes

Measure
Overall Survival
time frame: From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-up and every 6 months in long term follow-up
Time to first symptomatic skeletal event
time frame: From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-up
Radiological progression free survival
time frame: From randomization up to a maximum of 3 years, assessed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue
Time to radiological progression
time frame: From randomization up to a maximum of 3 years, assessed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue
Pain improvement rate, defined as the number of subjects with pain improvement divided by the total number of subjects evaluable for pain improvement
time frame: Up to 48 weeks
Time to pain progression
time frame: Up to 48 weeks
Number of participants with treatment-emergent adverse events or serious adverse events as a measure of safety and tolerability
time frame: From randomization up to 8 years
Change in 24-hour analgesic use
time frame: Up to 48 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Castration-resistant disease defined as: - Serum testosterone level: ≤ 50 ng/dL (1.7 nmol/L) - Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate - Serum PSA (Prostate specific antigen) progression defined as 2 subsequent increases in PSA over a previous reference value (a minimum of 2 ng/mL [μg/L]) OR - Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression - Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone. - Two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization Exclusion Criteria: - History of visceral metastasis, or visceral metastases - Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter - Central nervous system (CNS) metastases - Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up - Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone) - Prior treatment with radium-223 dichloride - Prior systemic radiotherapy and hemibody external radiotherapy

Additional Information

Official title A Three Arm Randomized, Open-label Phase II Study of Radium-223 Dichloride 50 kBq/kg (55 kBq/kg After Implementation of NIST Update) Versus 80 kBq/kg (88 kBq/kg After Implementation of NIST Update), and Versus 50 kBq/kg (55 kBq/kg After Implementation of NIST Update) in an Extended Dosing Schedule in Subjects With Castration-resistant Prostate Cancer Metastatic to the Bone
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.