Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer

NCT00967954 | Unknown

• 3 other identifiers: CDR0000639017CRUK-CHIRRPEU-20920
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

antiandrogen therapy DRUG

releasing hormone agonist therapy DRUG

DNA analysis GENETIC

RNA analysis GENETIC

comparative genomic hybridization GENETIC

gene expression analysis GENETIC

laboratory biomarker analysis OTHER

diffusion-weighted magnetic resonance imaging PROCEDURE

magnetic resonance spectroscopic imaging PROCEDURE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (1)

Cancer Research UK at Cambridge Research Institute

Cambridge, England, CB2 0RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Comparative Genomic Hybridization; Gene Expression Profiling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Vincent Gnanapragasam, MD

  Cancer Research UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2009-08

Locations

GB (1)