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Prostate Cancer Clinical Trials

Alpharadin® with Docetaxel for Castration-Resistant Prostate Cancer (20121484)
A PhaseI/IIa Study of Safety and Efficacy of Alpharadin® with Docetaxel in Patients with Bone Metastases from Castration-Resistant Prostate Cancer
Status Conditions Phase Study ID
Closed Prostate Cancer Phase I/II 20121484
NCT01106352
Summary

The main purpose of this study is to establish a recommended dose of Alpharadin® to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.


Investigator
Tia Higano, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Main Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry
  • Known castration-resistant disease
  • Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1)
  • Life expectancy at least 6 months.
  • Acceptable hematology and serum biochemistry screening values
  • Eligible for use of docetaxel according to the product information (package insert or similar).
Exclusions (conditions that would prevent participation in this study)

Main Exclusion Criteria:

  • Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period.
  • Has received external radiotherapy within the last 4 weeks prior to start of study treatment.
  • Has an immediate need for radiotherapy.
  • Has received prior hemibody external radiotherapy .
  • Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases.
  • Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier.
  • Has received more than ten previous infusions of docetaxel.
  • Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation.
  • Previous use of G-CSF for persistent neutropenia after docetaxel treatment.
  • Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment.
  • Has received prior treatment with Alpharadin.
  • Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
  • Symptomatic nodal disease, i.e. scrotal, penile or leg edema.
  • Visceral metastases from CRPC (>2 lung and/or liver metastases [size ≥2cm]), as assessed by CT scan of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment.
  • Uncontrolled loco-regional disease.
  • Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
  • Has imminent or established spinal cord compression based on clinical findings and/or MRI.
  • Unmanageable fecal incontinence.
Last Updated
September 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.