Metastatic Prostate CancerPhase 4NCT00255268
CMAB vs IMAB in Metastatic Prostate Cancer
A Phase 4 study testing Goserelin and Bicalutamide in people with Metastatic Prostate Cancer, run by AstraZeneca at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Goserelin and Bicalutamide
- How many people
- 15 participants
- Where
- 2 sitesMexico
- Study dates
- Aug 2004to not given
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of D2 of Adenocarcinoma,
- Naivety to treatment
- Valuable bone metastasis
Who cannot join
- Hematological, liver or renal toxicity Grade IV
- Severe and active infections
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Goserelin, Bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
BicalutamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Secondary outcomes (2)
Safety
Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2005 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Mexico Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255268
- Sponsor's protocol ID
- D6876L00010
- Status last verified
- Aug 2007
- First submitted
- 26 Oct 2005
- Last updated
- 28 Aug 2007
- Results posted
- No