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

Prostate Cancer Clinical Trial

Official title:

A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00967954
• Other study ID #: CDR0000639017
• Secondary ID: CRUK-CHIRRPEU-20
• Status: Recruiting
• Phase: N/A
• First received: August 27, 2009
• Last updated: January 9, 2014
• Start date: September 2008

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• antiandrogen therapy

• releasing hormone agonist therapy

Genetic:
• DNA analysis

• RNA analysis

• comparative genomic hybridization

• gene expression analysis

Other:
• laboratory biomarker analysis

Procedure:
• diffusion-weighted magnetic resonance imaging

• magnetic resonance spectroscopic imaging

Locations

Country	Name	City	State
United Kingdom	Cancer Research UK at Cambridge Research Institute	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of molecular and pathophysiological changes			No
Primary	Functional imaging as a non-invasive tool to measure treatment response			No
Primary	Development of clinical models to predict tumor response			No