Docetaxel + Radium 223 for Prostate Cancer
Trial Summary
What is the purpose of this trial?
The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A total of approximately 18 subjects will take part in the dose escalation part of the study and an additional 25 subjects will participate in the expansion cohort. This study will be conducted across four centers in the United States.
Will I have to stop taking my current medications?
The trial requires that you stop antiandrogen therapy at least 4 weeks before enrolling, unless you have specific progression criteria. Additionally, you must not have taken any myelosuppressive agents within 30 days of enrollment.
What data supports the effectiveness of the drug Docetaxel in treating prostate cancer?
Is the combination of Docetaxel and Radium 223 safe for prostate cancer treatment?
How is the drug combination of Docetaxel and Radium 223 unique for treating prostate cancer?
This drug combination is unique because it combines Docetaxel, which targets cancer cells directly, with Radium 223, which specifically targets bone metastases (cancer spread to bones) using alpha particles. This dual approach aims to improve survival by addressing both the tumor and its spread to bones, which is a common issue in advanced prostate cancer.910111213
Research Team
Paul Mathew, MD
Principal Investigator
Tufts Medical Center
Eligibility Criteria
This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy. They must have a good level of blood cells, no severe liver issues, and at least two bone metastases. Men should be on ongoing castration treatment and agree to use birth control if applicable. Those with certain lung or liver metastases, neuroendocrine differentiation, severe neuropathy, other cancers needing treatment, brain metastases or bad reactions to docetaxel can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lead-in
4-week lead-in period with docetaxel monotherapy to assess for docetaxel intolerance
Treatment
Combination therapy with Ra-223 every 4 weeks for 6 cycles in a dose-escalation design
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Docetaxel
- Radium 223
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Lahey Clinic
Collaborator
Henry Ford Hospital
Collaborator
Ohio State University Comprehensive Cancer Center
Collaborator