Metastatic Prostate Cancer Clinical Trial
Official title:
Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer
| NCT number | NCT00255268 |
| Other study ID # | D6876L00010 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 4 |
| First received | October 26, 2005 |
| Last updated | August 24, 2007 |
| Start date | August 2004 |
| Verified date | August 2007 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Mexico: Ministry of Health |
| Study type | Interventional |
To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.
| Status | Withdrawn |
| Enrollment | 15 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histological diagnosis of D2 of Adenocarcinoma, - Naivety to treatment - Valuable bone metastasis Exclusion Criteria: - Hematological, liver or renal toxicity Grade IV - Severe and active infections |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Research Site | Metepec | |
| Mexico | Research Site | Mexico City |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to progression | |||
| Secondary | Safety | |||
| Secondary | Quality of Life |
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