Clinical trial NCT00967954: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-08-28
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Identification of molecular and pathophysiological changes
measure: Functional imaging as a non-invasive tool to measure treatment response
measure: Development of clinical models to predict tumor response
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cancer Research UK at Cambridge Research Institute
state: England
Study officials:
affiliation: Cancer Research UK
name: Vincent Gnanapragasam, MD
role: PRINCIPAL_INVESTIGATOR
References: