Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC) - Dora trial

Memorial Sloan Kettering Cancer Center0 sites738 target enrollmentNovember 20, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with histological or cytological proof of Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 738
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 20, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•Inclusion Criteria:
•Willing and able to provide, or have a legally authorized representative provide, written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
•NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
•Males 18 years of age and above
•Histological or cytological proof of prostate cancer
•Documented progressive mCRPC based on at least one of the following criteria:
•1\.a)PSA progression defined as a minimum of 2 rising PSA levels with a minimum of a 1 week interval between each determination. A minimum PSA of 1\.0 ng/mL is required for study entry.
•2\.Soft\-tissue progression defined as an increase \= 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
•3\.Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
•Two or more bone lesions defined by nuclear bone scan

•Exclusion Criteria:
•3\.2\.1Received any other investigational therapeutic agents or other anticancer therapies within 2 weeks or 5 half\-lives, whichever is shorter, prior to randomization.
•Received external beam radiotherapy within the 2 weeks prior to randomization.
•Has an immediate need for external beam radiotherapy.
•Has received any other systemic investigational or anti\-cancer radiopharmaceutical in the past.
•Has received any prostate cancer directed chemotherapy in the castration resistant setting.
•Has received \> 6 prior doses of docetaxel in the castration sensitive setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
•Has received four or more systemic anticancer regimens for mCRPC.
•?Treatment with docetaxel or abiraterone for non\-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
•?A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.