DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
N
Nabil Adra, MD
Primary Investigator
Enrolling By Invitation
18-100 years
Male
Phase
3
2 Locations
Overview
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Prostate Cancer
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Age: Between 18 Years - 100 Years
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Gender: Male
Inclusion Criteria
- Histological or cytological proof of prostate cancer
- Documented progressive mCRPC
- Two or more bone lesions
- Normal organ function with acceptable initial laboratory values within 14 days of randomization
- 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.
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
- 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).
- 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
Updated on
20 May 2024.
Study ID: 1808220234 (C16-174)
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