Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (NCT03737370) | Clinical Trial Compass
CompletedPhase 1
Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer
United States43 participantsStarted 2018-01-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate
✓. Documented metastatic castration resistant disease with PSA progression, radiographic progression, or both, despite medical or surgical castration
✓. Two or more bone metastases detected on skeletal scintigraphy
✓. Eligible for docetaxel chemotherapy
✓. ECOG Performance Status 0-2
✓. Adequate organ function:
✓. Hemoglobin \> 10 g/dL
✓. Absolute Neutrophil Count ≥ 1,500 K/mL
Exclusion criteria
✕. Prior radionuclide therapy for CRPC
✕. Prior docetaxel for CRPC. (Permitted if given for castration sensitive disease \> 6 months prior).
✕. Antiandrogen therapy within 4 weeks of enrollment. However, patients with primary failure of secondary anti-androgen therapy OR symptomatic progression, objective progression and/or biochemical evidence of rising PSA less than 4 weeks after discontinuation of anti-androgen therapy will not have anti-androgen withdrawal responses and will not be excluded.
✕. Preexisting peripheral neuropathy grade 2 or higher.