Prostate CancerNCT00967954
Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
A study testing antiandrogen therapy, releasing hormone agonist therapy and DNA analysis in people with Prostate Cancer, run by Cancer Research UK at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- antiandrogen therapy, releasing hormone agonist therapy and DNA analysis
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Research UK at Cambridge Research Institute
Cambridge, England, CB2 0RE
Vincent Gnanapragasam, MD, 44-1223-348-363
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- antiandrogen therapy, releasing hormone agonist therapy, DNA analysis, RNA analysis, comparative genomic hybridization
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiandrogen therapyDrug
releasing hormone agonist therapyDrug
DNA analysisGenetic
RNA analysisGenetic
comparative genomic hybridizationGenetic
gene expression analysisGenetic
laboratory biomarker analysisOther
diffusion-weighted magnetic resonance imagingProcedure or surgery
magnetic resonance spectroscopic imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Vincent Gnanapragasam, MD, Principal investigator, Cancer Research UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967954
- Sponsor's protocol ID
- CDR0000639017
- Other IDs
- CRUK-CHIRRP, EU-20920
- Status last verified
- Aug 2009
- First submitted
- 27 Aug 2009
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer
- ClinicalTrials.gov ID
- NCT00967954
- Acronym / sponsor ID
- CDR0000639017
- Conditions
- Prostate Cancer
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2013 (estimated)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | – |
| magnetic resonance spectroscopic imaging | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gnanapragasam, MD principal investigator
Cancer Research UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antiandrogen therapy, releasing hormone agonist therapy and DNA analysis in people with Prostate Cancer, run by Cancer Research UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of molecular and pathophysiological changes. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.