Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574571
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE June 20, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE June 19, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
Overall survival [ Time Frame: 2 years ]
Overall survival is defined as the time from randomization to death from any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03574571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer
Official Title  ICMJE Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Docetaxel 75 mg/m2
    Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
  • Drug: Docetaxel 60 mg/m2
    Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.
  • Drug: Radium-223
    Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
Study Arms  ICMJE
  • Experimental: Docetaxel
    Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.
    Intervention: Drug: Docetaxel 75 mg/m2
  • Experimental: Docetaxel with Radium-223
    Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
    Interventions:
    • Drug: Docetaxel 60 mg/m2
    • Drug: Radium-223
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
738
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Prostate
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Morris, MD 646-422-4469 morrism@mskcc.org
Contact: Josef Fox, MD 212-639-7371
Listed Location Countries  ICMJE Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03574571
Other Study ID Numbers  ICMJE 18-150
2018-002944-10 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Bayer
Investigators  ICMJE
Principal Investigator: Michael Morris, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP