ACTIVE_NOT_RECRUITING

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

Conditions

Prostate Cancer Radium-223 Docetaxel 18-150 C16-174 DORA Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-06-19

Study Completion:2027-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03574571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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	* 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

Inclusion Criteria

Exclusion 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.
* 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

* 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

Contacts and Locations

Principal Investigator

Michael Morris, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

United States

Yale University- Yale Cancer Center

New Haven, Connecticut, 06510

United States

Helen Graham Cancer Center (Christiana Care)

Newark, Delaware, 19713

United States

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

United States

Mount Sinai Medical Center (Miami)

Miami, Florida, 33140

United States

Rush University Medical Center

Chicago, Illinois, 606012

United States

Indiana University

Indianapolis, Indiana, 46202

United States

Ochsner Cancer Institute

New Orleans, Louisiana, 70121

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

University of Massachusetts

Worcester, Massachusetts, 01655

United States

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Nebraska Cancer Specialists

Omaha, Nebraska, 68114

United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, 68130

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

New Jersey Urology

Saddle Brook, New Jersey, 07663

United States

New Mexico Oncology and Hematology

Albuquerque, New Mexico, 87109

United States

University of Buffalo

Buffalo, New York, 14203

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, 10065

United States

Bronx VA Hospital

New York, New York, 10468

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

University of North Carolina

Chapel Hill, North Carolina, 27514

United States

Atrium Health/ Levine Cancer Institute

Monroe, North Carolina, 28112

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

Dayton Physicians Network

Kettering, Ohio, 45409

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Houston Methodist Research Institute

Houston, Texas, 77030

United States

Millennium Physicians

Houston, Texas, 77090

United States

University of Washington

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Michael Morris, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-19

Study Completion Date2027-04-01

Study Record Updates

Study Start Date2018-06-19

Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

Radium-223
Docetaxel
18-150
C16-174
DORA Trial

Additional Relevant MeSH Terms

Prostate Cancer