Prostate CancerPhase 1NCT00989105
Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer
A Phase 1 study testing immunohistochemistry staining method, laboratory biomarker analysis and pharmacological study in people with Prostate Cancer, run by Cancer Research UK at 1 site in United Kingdom.
Trial summary
RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- immunohistochemistry staining method, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer meeting 1 of the following criteria:
- Disease confined to the prostate that is to be treated with radical prostatectomy after imaging
- Locally advanced disease that is to be treated with radiotherapy
- Patients must agree to undergo surgical pelvic lymph node staging to assist with determination of radiation fields
- Metastatic disease at initial diagnosis or recurrent or progressive disease
- Patients receive standard of care
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Neutrophils ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 times ULN
- Must be registered with the Cancer Research UK Drug Development Office
- Capable of cooperating with imaging procedure and follow-up
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
- No history of recent significant cardiac arrhythmia
- No prior NYHA class III-IV cardiac disease or concurrent congestive heart failure
- No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No chemotherapy or radiotherapy prior to or within 2 weeks of study therapy
- No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered
- No other concurrent investigational drugs
- Concurrent anticancer therapy allowed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Saint Bartholomew's Hospital
London, England, EC1A 7BE
About this study
Official title: A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of Prostate Cancer
RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease.
PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the safety of technetium Tc 99m (^99mTc) demobesin-4 (DB4) in patients with prostate cancer.
- To assess the biodistribution of ^99mTc DB4 in these patients.
- To assess the pharmacokinetics of ^99mTc DB4 in these patients.
Secondary
- To assess the performance of ^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients.
Tertiary
- To compare uptake of ^99mTc DB4 with levels of expression in gastrin-releasing peptide receptor in prostate tumor samples and lymph node specimens.
OUTLINE: Patients are stratified according to diagnosis (cancer confined to prostate vs locally advanced disease vs metastatic disease).
Patients receive technetium Tc 99m (^99mTc) demobesin-4 (DB4) IV bolus over 1 minute and undergo imaging by single photon emission computer tomography, CT scan, and/or MRI up to 3 hours after infusion. Some patients undergo radical prostatectomy or surgical pelvic lymph node biopsies.
Blood and urine samples are collected at 5, 10, 20, 30, and 45 minutes at baseline and at 1, 2, 3, 4, and 6 hours after ^99mTc DB4 IV infusion for pharmacokinetic studies. Tumor tissue samples obtained during radical prostatectomy and surgical lymph node biopsies are analyzed for gastrin-releasing peptide receptor by IHC.
After completion of study intervention, patients are followed for up to 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
- Conditions
- Prostate Cancer
- Being tested
- immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, computed tomography, magnetic resonance imaging
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent 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.
laboratory biomarker analysisOther
computed tomographyProcedure or surgery
magnetic resonance imagingProcedure or surgery
single photon emission computed tomographyProcedure or surgery
technetium Tc 99m demobesin-4Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Causality of each adverse events as assessed by NCI CTCAE v. 3.0
Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
Secondary outcomes (2)
Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI)
Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
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 1
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Avril, MD, Principal investigator, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989105
- Sponsor's protocol ID
- CDR0000650867
- Other IDs
- UKM-ICRF-CR0402-11, CRUK-CR0402-11, EUDRACT-2007-005324-32, EU-20981
- Status last verified
- Feb 2012
- First submitted
- 1 Oct 2009
- Last updated
- 28 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00989105
- Acronym / sponsor ID
- CDR0000650867
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Oct 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: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease.
PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the safety of technetium Tc 99m (^99mTc) demobesin-4 (DB4) in patients with prostate cancer.
- To assess the biodistribution of ^99mTc DB4 in these patients.
- To assess the pharmacokinetics of ^99mTc DB4 in these patients.
Secondary
- To assess the performance of ^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients.
Tertiary
- To compare uptake of ^99mTc DB4 with levels of expression in gastrin-releasing peptide receptor in prostate tumor samples and lymph node specimens.
OUTLINE: Patients are stratified according to diagnosis (cancer confined to prostate vs locally advanced disease vs metastatic disease).
Patients receive technetium Tc 99m (^99mTc) demobesin-4 (DB4) IV bolus over 1 minute and undergo imaging by single photon emission computer tomography, CT scan, and/or MRI up to 3 hours after infusion. Some patients undergo radical prostatectomy or surgical pelvic lymph node biopsies.
Blood and urine samples are collected at 5, 10, 20, 30, and 45 minutes at baseline and at 1, 2, 3, 4, and 6 hours after ^99mTc DB4 IV infusion for pharmacokinetic studies. Tumor tissue samples obtained during radical prostatectomy and surgical lymph node biopsies are analyzed for gastrin-releasing peptide receptor by IHC.
After completion of study intervention, patients are followed for up to 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
| computed tomography | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| single photon emission computed tomography | Procedure or surgery | – |
| technetium Tc 99m demobesin-4 | Radiation | – |
Primary outcome
Causality of each adverse events as assessed by NCI CTCAE v. 3.0
Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
2 secondary outcomes
Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI)
Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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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.
Norbert Avril, MD principal investigator
St. Bartholomew's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing immunohistochemistry staining method, laboratory biomarker analysis and pharmacological study 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.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Causality of each adverse events as assessed by NCI CTCAE v. 3.0. 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 28 Feb 2012.