A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)
Condition: Metastatic Castrate Resistant Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03737370
Sponsor: Tufts Medical Center
Phase: Phase 1
- Age: minimum 18 Years maximum N/A
- Gender: All
- 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
- Platelet count ≥ 150,000 x 10^9/L
- Total bilirubin ≤ 1.5x upper limit of normal range, excluding Gilbert syndrome
- Serum AST ≤ 1.5 x upper limit of normal range
- Serum ALT ≤ 1.5 x upper limit of normal range
- Estimated glomerular filtration rate (GFR) > 30mL/min
- Ongoing castration (androgen deprivation therapy or prior orchiectomy)
- Male subjects with female sexual partners of childbearing potential must agree to use at least one highly effective methods of birth control.
- Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures.
- Age ≥ 18 years
- 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.
- Other serious medical condition as judged by the investigator.
- Active second malignancy that requires therapy.
- Known brain or leptomeningeal metastases
- Concurrent enrollment in any other investigational anticancer therapy
- Treatment with any myelosuppressive agent within 30 days of enrollment
- Presence of bulky visceral metastases, defined as any of the following:
- ≥ 4 lung lesions (at least 1cm each in size in the longest diameter) or pulmonary lymphangitic metastasis
- Liver metastases with sum of lesion diameters totaling ≥ 5cm
- Evidence of neuroendocrine or small cell differentiation on prior biopsy
- History of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80
View trial on ClinicalTrials.gov