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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03574571
Other study ID # 18-150
Secondary ID 2018-002944-10
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 19, 2018
Est. completion date June 1, 2026

Study information

Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact Michael Morris, MD
Phone 646-422-4469
Email morrism@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.


Recruitment information / eligibility

Status Recruiting
Enrollment 738
Est. completion date June 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Willing and able to 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. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. 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 - ECOG 0- 1 - Normal organ function with acceptable initial laboratory values within 14 days of randomization: - Albumin > 30 g/L - ANC = 1.5 x 10^9/L - Hemoglobin = 10 g/dL - Platelet count = 100 x 10^9/L - Creatinine = 1.5 x the institutional upper limit of normal (ULN) - Bilirubin = ULN (unless documented Gilbert's disease) - SGOT (AST) = 1.5 x ULN - SGPT (ALT) = 1.5 x ULN - WBC count = 3 x 10^9/L - Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent. - Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy. - All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less. - Willing and able to comply with the protocol, including follow-up visits and examinations Exclusion Criteria: - Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization. - Received external beam radiotherapy within the 4 weeks prior to randomization. - Has an immediate need for external beam radiotherapy. - Has received any systemic bone-seeking radiopharmaceutical in the past. - Has received any prostate cancer directed chemotherapy in the castration resistant 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. - Has known Grade =3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation. - Has received blood transfusions or growth factors within the last 4 weeks prior to randomization. - Symptomatic nodal disease (i.e., scrotal, penile, or leg edema). - Has visceral metastases with = 3 lung and/or liver metastases or individual lesion =2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization. - Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms. - Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for = 3 years. - Has imminent or established cord compression based on clinical findings and/or MRI. - Known bone marrow dysplasia - Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans - Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to: - Uncontrolled infection - NYHA III or IV heart failure - Crohn's disease or those with ulcerative colitis who have not undergone a colectomy - Known active infection with HIV, Hepatitis B or Hepatitis C

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.
Radium-223
Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Locations

Country Name City State
Netherlands Noordwest Ziekenhuisgrouep Alkmaar (NWZ) Alkmaar
Netherlands Ziekenhuisgroep Twente (ZGT) Almelo
Netherlands Nederlands Kanker Instituut (Data Collection Only) Amsterdam Plesmanlaan 121
Netherlands Amphia Hospital Breda
Netherlands Haaglanden Medical Center Den Haag
Netherlands Deventer Ziekenhuis Deventer
Netherlands Tergooi Hospital Hilversum
Netherlands Canisius Wilhelmina Ziekenhuis (CWZ) Nijmegen
Netherlands Erasmus MC Cancer Institute Rotterdam
Netherlands Franciscus Gasthuis & Vlietland Rotterdam
Netherlands Maasstad Hospital Rotterdam
Netherlands St. Antonius Ziekenhuis (Utrecht) Utrecht
Netherlands Isala Kliniek Zwolle
Spain Hospital Del Mar (Data Collection Only) Barcelona
Spain Vall d'Hebron Institute of Oncology (VHIO) (Data Collection Only) Barcelona
Spain Hospital Universitario 12 de Octubre (Data Collection Only) Madrid
Spain Ramón y Cajal Hospital Madrid Community Of Madrid
Spain HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO (Data Collection Only) Sevilla
Spain Instituto Valenciano de Oncología (Data Collection Only) Valencia
United States New Mexico Oncology and Hematology Albuquerque New Mexico
United States University of Michigan Cancer Center Ann Arbor Michigan
United States MidLantic Urology Bala-Cynwyd Pennsylvania
United States University of Maryland Medical Center Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Boca Raton Regional Hospital Boca Raton Florida
United States Roswell Park Cancer Institute Buffalo New York
United States University of Buffalo Buffalo New York
United States MD Anderson Cancer Center at Cooper Camden New Jersey
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Rush University Medical Center Chicago Illinois
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Memorial Sloan Kettering Westchester Harrison New York
United States Houston Methodist Research Institute Houston Texas
United States Millennium Physicians Houston Texas
United States Indiana University Indianapolis Indiana
United States Dayton Physicians Network Kettering Ohio
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Mount Sinai Medical Center (Miami) Miami Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States University of Minnesota Minneapolis Minnesota
United States Atrium Health/ Levine Cancer Institute Monroe North Carolina
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Yale University- Yale Cancer Center New Haven Connecticut
United States Ochsner Cancer Institute New Orleans Louisiana
United States Bronx VA Hospital New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York Presbyterian Hospital-Weill Medical College of Cornell University New York New York
United States Helen Graham Cancer Center (Christiana Care) Newark Delaware
United States University of Oklahoma Oklahoma City Oklahoma
United States Nebraska Cancer Specialists Omaha Nebraska
United States XCancer Omaha / Urology Cancer Center Omaha Nebraska
United States University of Rochester Medical Center Rochester New York
United States Memorial Sloan Kettering Rockville Centre Rockville Centre New York
United States New Jersey Urology Saddle Brook New Jersey
United States University of Washington Seattle Washington
United States Memorial Sloan Kettering Nassau Uniondale New York
United States University of Massachusetts Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Bayer

Countries where clinical trial is conducted

United States,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Overall survival is defined as the time from randomization to death from any cause. 2 years
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