Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
antiandrogen therapy
releasing hormone agonist therapy
DNA analysis
RNA analysis
comparative genomic hybridization
gene expression analysis
laboratory biomarker analysis
diffusion-weighted magnetic resonance imaging
magnetic resonance spectroscopic imaging
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
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
Sites / Locations
- Cancer Research UK at Cambridge Research InstituteRecruiting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967954
Brief Title
Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
Official Title
A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research UK
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
antiandrogen therapy
Intervention Type
Drug
Intervention Name(s)
releasing hormone agonist therapy
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
RNA analysis
Intervention Type
Genetic
Intervention Name(s)
comparative genomic hybridization
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Primary Outcome Measure Information:
Title
Identification of molecular and pathophysiological changes
Title
Functional imaging as a non-invasive tool to measure treatment response
Title
Development of clinical models to predict tumor response
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Gnanapragasam, MD
Organizational Affiliation
Cancer Research UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Research UK at Cambridge Research Institute
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Gnanapragasam, MD
Phone
44-1223-348-363
12. IPD Sharing Statement
Learn more about this trial
Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
We'll reach out to this number within 24 hrs