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CMAB vs IMAB in Metastatic Prostate Cancer

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00255268
Enrollment
15
Registered
2005-11-18
Start date
2004-08-31
Completion date
Unknown
Last updated
2007-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Prostate Cancer

Brief summary

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.

Interventions

DRUGGoserelin
DRUGBicalutamide

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to progression

Secondary

MeasureTime frame
Safety
Quality of Life

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026