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CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate CancerUnique Dataset IDnci-data-34ClinicalTrial.gov IDNCT00309985
As of November 6, 2017, there are four different datasets available for NCT00309985. This is NCT00309985-D4. NCT00309985-D1 and NCT00309985-D3 each contain the same clinical data. NCT00309985-D2 and NCT00309985-D4 each contain the same toxicity data. NCT00309985-D1 and NCT00309985-D2 were the original two submissions. NCT00309985-D3 and NCT00309985-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00309985-D3 and NCT00309985-D4 be used.
Clinical Trial Title
CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Trial Summary and Conditions
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer. PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
See data dictionary for more details.
Primary: Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer. Secondary: Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone. Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone. Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone. Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm. Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone. Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire. Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival. Tertiary: Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer. Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes. Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis.
Primary: Overall Survival [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Secondary: Time to Clinical Progression [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Proportion of Patients With PSA Complete Response (CR) at 6 Months [ Time Frame: Assessed at 6 months ] Proportion of Patients With PSA Complete Response (CR) at 12 Months [ Time Frame: Assessed at 12 months ] QOL Change From Baseline to 3 Months [ Time Frame: Assessed at baseline and 3 months ]"
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00309985-D4-Data-Dictionary.pdf