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Active, not recruiting Phase 3

A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

NCT03574571 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2018-06-19
Last updated
2026-05-14

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Docetaxel 75 mg/m2 →Docetaxel 60 mg/m2 →Radium-223 →

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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. °Note: If this requirement to have a washout of 2 weeks or 5 half-lives prior to randomization causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at pcctc@mskcc.org to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start. * Received external beam radiotherapy within the 4 weeks prior to randomization. ° Note: If prolonging randomization to complete EBRT washout causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at pcctc@mskcc.org to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start. * 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

Primary outcome measure(s)

  • Overall survival — 2 years
    Overall survival is defined as the time from randomization to death from any cause.

Trial sites (72)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Yale University- Yale Cancer Center New Haven Connecticut
Helen Graham Cancer Center (Christiana Care) Newark Delaware
Boca Raton Regional Hospital Boca Raton Florida
Mount Sinai Medical Center (Miami) Miami Florida
Rush University Medical Center Chicago Illinois
Indiana University Indianapolis Indiana
Ochsner Cancer Institute New Orleans Louisiana
University of Maryland Medical Center Baltimore Maryland
University of Massachusetts Worcester Massachusetts
University of Michigan Cancer Center Ann Arbor Michigan
University of Minnesota Minneapolis Minnesota
Nebraska Cancer Specialists Omaha Nebraska
XCancer Omaha / Urology Cancer Center Omaha Nebraska
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
MD Anderson Cancer Center at Cooper Camden New Jersey
Memorial Sloan Kettering Monmouth Middletown New Jersey
Memorial Sloan Kettering Bergen Montvale New Jersey
New Jersey Urology Saddle Brook New Jersey
New Mexico Oncology and Hematology Albuquerque New Mexico
University of Buffalo Buffalo New York
Roswell Park Cancer Institute Buffalo New York
Memorial Sloan Kettering Commack Commack New York
Memorial Sloan Kettering Westchester Harrison New York
Memorial Sloan Kettering Cancer Center New York New York
New York Presbyterian Hospital-Weill Medical College of Cornell University New York New York
Bronx VA Hospital New York New York
University of Rochester Medical Center Rochester New York
Memorial Sloan Kettering Nassau Uniondale New York
University of North Carolina Chapel Hill North Carolina
Atrium Health/ Levine Cancer Institute Monroe North Carolina
University of Cincinnati Medical Center Cincinnati Ohio
Dayton Physicians Network Kettering Ohio
University of Oklahoma Oklahoma City Oklahoma
MidLantic Urology Bala-Cynwyd Pennsylvania
Medical University of South Carolina Charleston South Carolina
Houston Methodist Research Institute Houston Texas
Millennium Physicians Houston Texas
University of Washington Seattle Washington

+ 32 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03574571 on ClinicalTrials.gov ↗ ← All trials in Spain