- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967954
Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood and tissue samples from patients with prostate cancer receiving androgen deprivation therapy.
Study Overview
Status
Conditions
Intervention / Treatment
- Genetic: gene expression analysis
- Other: laboratory biomarker analysis
- Procedure: diffusion-weighted magnetic resonance imaging
- Genetic: DNA analysis
- Genetic: RNA analysis
- Genetic: comparative genomic hybridization
- Procedure: magnetic resonance spectroscopic imaging
- Drug: antiandrogen therapy
- Drug: releasing hormone agonist therapy
Detailed Description
OBJECTIVES:
- To identify the molecular and pathophysiological changes which occur during the early stages of androgen deprivation (AD) and during emerging castration-resistant prostate cancer.
- To test functional imaging as a non-invasive tool to measure treatment response and validate this using biological endpoints.
- To develop clinical models to predict how tumors will respond to AD and identify new targets once AD fails.
OUTLINE:
- Group A: Patients likely to receive androgen deprivation (AD) as first-line therapy undergo blood and prostate biopsy sample collection before and after treatment on days 0 and 14 or 90. Patients receive an androgen receptor inhibitor followed by maintenance with a gonadotropin-releasing hormone analogue beginning on day 0. Patients also undergo diffusion-weighted MRI, MR spectroscopic imagining, quantitative T1W mapping, and T1W perfusion sequence.
- Group B: Patients already receiving AD undergo blood and prostate biopsy sample collection within 4 weeks of diagnosis of castration-resistant prostate cancer and before initiating any second-line therapy.
Blood and tissue samples are assessed via DNA and RNA genetic analysis, gene expression studies, and comparative genomic hybridization to identify novel markers of androgen response and resistance.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
-
Cambridge, England, United Kingdom, CB2 0RE
- Recruiting
- Cancer Research UK at Cambridge Research Institute
-
Contact:
- Vincent Gnanapragasam, MD
- Phone Number: 44-1223-348-363
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- High clinical suspicion of prostate cancer, based on an abnormal digital rectal examination and PSA (> 20 ng/mL)
Newly diagnosed, castration-resistant prostate cancer
- Clinical stage ≥ T2c disease
- Significant tumor volume on initial diagnostic biopsy (> 50% of cores)
- Likely to receive androgen deprivation therapy for prostate cancer
PATIENT CHARACTERISTICS:
- No contraindication to transrectal needle biopsy
- No contraindication to MRI or prostate needle biopsy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Identification of molecular and pathophysiological changes
|
Functional imaging as a non-invasive tool to measure treatment response
|
Development of clinical models to predict tumor response
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Gnanapragasam, MD, Cancer Research UK
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000639017
- CRUK-CHIRRP
- EU-20920
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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