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

Investigating the Effects of Radium-223 (a radioactive substance targeting bone metastases) with Chemotherapy in Prostate Cancer

Recruiting
19 months - 204 months
Male
Phase N/A
1 Location

Brief description of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer
  • Age: 19 months - 204 months
  • 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 19 Feb 2024. Study ID: 1808220234 (C16-174)

This study investigates the effects of combining radium-223 with a chemotherapy treatment called docetaxel in patients with prostate cancer that has spread to the bones. The study aims to compare the outcomes of this combination treatment with those of using docetaxel alone. Prostate cancer is a condition where cancer cells form in the tissues of the prostate, and when it spreads to other parts of the body, it is known as metastatic prostate cancer. Radium-223 is a type of radioactive substance that targets bone metastases, which are cancerous growths in the bone.

Participants in this study will receive either the combination of radium-223 and docetaxel or docetaxel alone. The study will involve monitoring the effects of the treatments on the participants' health and cancer progression. Participants will be required to follow specific guidelines regarding birth control and will not be allowed to donate sperm during the study and for a period after the study ends. The study will also monitor for any side effects or changes in the participants' condition.

  • Who can participate: Men with prostate cancer that has spread to the bones and is progressing despite previous treatments can participate. Participants must have two or more bone lesions, have normal organ function, and agree to use birth control methods.
  • Study details: Participants will receive either radium-223 combined with docetaxel or docetaxel alone. They must follow birth control guidelines and cannot donate sperm during the study and for 30 days after. A placebo is not used in this study.

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