Prostate CancerPhase 1NCT00676286
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
A Phase 1 study testing 3T MR Imaging, C-Choline PET Scanning and Gene Rearrangement in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive. 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?
- 3T MR Imaging, C-Choline PET Scanning and Gene Rearrangement
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Mar 2016
- 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
Who may be able to join
- Histologically proven adenocarcinoma of the prostate
- Registration must occur within 16 weeks of last biopsy
- History and physical exam (including DRE) within 8 weeks prior to registration
- Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
- Patients must have a minimum of six biopsies (sextant) at registration
- PSA test within 8 weeks registration
Show all 10Show fewer
- Creatinine level below 100 umol/L within 8 weeks of registration
- Patients must have no contraindications to MRI scans
- No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
- Patients must be reliable for follow up
Who cannot join
- Patient does not have histologically-proven adenocarcinoma of the prostate
- Last biopsy greater than 16 weeks prior to registration
- History and physical exam (including DRE) greater that 8 weeks prior to registration
- Patient does not have indolent disease
- Patient has less than six sextant biopsies at registration
- PSA test done greater than 8 weeks from registration
Show all 10Show fewer
- Creatinine level greater than 100 umol/L within 8 weeks of registration
- Contraindications to MRI scans
- History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
- Patients that are not reliable for follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.
Read the detailed description
This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.
- Conditions
- Prostate Cancer
- Being tested
- 3T MR Imaging, C-Choline PET Scanning, Gene Rearrangement
- Keywords
- Prostate cancer active surveillance, 3 Tesla MR biological imaging in prostate cancer, tumor gene re-arrangements in 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.
3T MR ImagingProcedure or surgery
3TR Imaging
C-Choline PET ScanningProcedure or surgery
C-Choline PET Scanning
Gene RearrangementProcedure or surgery
Gene Rearrangement
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective to determine if we can accrue patients to this study in a timely manner.
Measured: 2 years
Secondary outcomes (8)
Patient compliance
Measured: Patients followed for 5 years from baseline
Optimal imaging parameters to characterize prostate cancers
Measured: patients followed for 5 years from baseline
feasibility of detecting gene arrangements in prostate biopsies
Measured: patients followed for 5 years from baseline
Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol
Measured: patients followe for 5 years from baseline
The natural history of prostate cancer with these investigations
Measured: patients followed for 5 years from baseline
The sensitivity and specificity of these investigation in detecting prostate cancer
Measured: patients followed for 5 years from baseline
The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease
Measured: patients followed for 5 years from baseline
The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression
Measured: patients followed for 5 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2016
- Study completionMar 2016
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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nawaid Usmani, MD, FRCPC, Study chair, Cross Cancer InstituteNawaid Usmani, MD, FRCPC, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676286
- Sponsor's protocol ID
- GU-24152
- Status last verified
- Jul 2016
- First submitted
- 12 May 2008
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
- ClinicalTrials.gov ID
- NCT00676286
- Acronym / sponsor ID
- GU-24152
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer active surveillance, 3 Tesla MR biological imaging in prostate cancer, tumor gene re-arrangements in prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 May 2008 (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.
This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.
Detailed description
This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven adenocarcinoma of the prostate
- Registration must occur within 16 weeks of last biopsy
- History and physical exam (including DRE) within 8 weeks prior to registration
- Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
- Patients must have a minimum of six biopsies (sextant) at registration
Key exclusion criteria (10 listed)
- Patient does not have histologically-proven adenocarcinoma of the prostate
- Last biopsy greater than 16 weeks prior to registration
- History and physical exam (including DRE) greater that 8 weeks prior to registration
- Patient does not have indolent disease
- Patient has less than six sextant biopsies at registration
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 |
|---|---|---|
| 3T MR Imaging3TR Imaging | Procedure or surgery | – |
| C-Choline PET ScanningC-Choline PET Scanning | Procedure or surgery | – |
| Gene RearrangementGene Rearrangement | Procedure or surgery | – |
Primary outcome
Primary objective to determine if we can accrue patients to this study in a timely manner.
Time frame: 2 years
8 secondary outcomes
Patient compliance
Time frame: Patients followed for 5 years from baseline
Optimal imaging parameters to characterize prostate cancers
Time frame: patients followed for 5 years from baseline
feasibility of detecting gene arrangements in prostate biopsies
Time frame: patients followed for 5 years from baseline
Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol
Time frame: patients followe for 5 years from baseline
The natural history of prostate cancer with these investigations
Time frame: patients followed for 5 years from baseline
The sensitivity and specificity of these investigation in detecting prostate cancer
Time frame: patients followed for 5 years from baseline
The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease
Time frame: patients followed for 5 years from baseline
The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression
Time frame: patients followed for 5 years from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Nawaid Usmani, MD, FRCPC study chair
Cross Cancer Institute
Nawaid Usmani, MD, FRCPC principal investigator
Cross Cancer Institute
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 3T MR Imaging, C-Choline PET Scanning and Gene Rearrangement in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. 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: finished, as of the sponsor's last update on 6 Jul 2016. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary objective to determine if we can accrue patients to this study in a timely manner. (time frame: 2 years). 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 6 Jul 2016.