Prostate CancerNCT01745718
Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer
A study testing Cytological imprints in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer. It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue. The strategy is used in other types of cancer, e.g lung, breast etc Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cytological imprints
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2012to Sep 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
Who may be able to join
- Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
- No previous prostate biopsies
- Positive MRI
- Signed letter of informed concent
Who cannot join
- Contraindications to MRI
- Previous prostate biopsies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.
It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.
The strategy is used in other types of cancer, e.g lung, breast etc
Read the detailed description
Background:
When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.
Aim:
The correlation between cytological imprints and histology of targeted prostate biopsies
Material\&Method:
All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:
- Preoperative MRI and targeted biopsies + random biopsies .
- Random biopsies (gold standard).
Only patients with a positive MRI were included in this collateral study.
The cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.
- Conditions
- Prostate Cancer
- Being tested
- Cytological imprints
- Keywords
- prostate cancer, targeted biopsies, cytological imprints, histology
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytological imprintsOther
Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
| Study group | Role | What they receive |
|---|---|---|
| MRI and targeted biopsies | Other | All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints. Receives: Other: Cytological imprints |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard). Measure of agreement, sensitivity and specificity will be calculated.
Measured: 15 months
Secondary outcomes (1)
Interobserver variability
The cytological imprints will be evaluated by three different cytologists and classified as either negative or positive. The results will be compared to the histology which defines the gold standard. Any difference in evaluation will be assessed.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionSep 2013
Why it stopped: The study was stopped for technical reasons
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduard Baco, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745718
- Sponsor's protocol ID
- OsloUH_2
- Status last verified
- Sep 2015
- First submitted
- 20 Nov 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Biopsies and the Role of Cytological Imprints for Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01745718
- Acronym / sponsor ID
- OsloUH_2
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, targeted biopsies, cytological imprints, histology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped for technical reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Dec 2012 (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.
The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.
It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.
The strategy is used in other types of cancer, e.g lung, breast etc
Detailed description
Background:
When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.
Aim:
The correlation between cytological imprints and histology of targeted prostate biopsies
Material\&Method:
All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:
- Preoperative MRI and targeted biopsies + random biopsies .
- Random biopsies (gold standard).
Only patients with a positive MRI were included in this collateral study.
The cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI and targeted biopsies | Other | Other: Cytological imprintsAll patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
- No previous prostate biopsies
- Positive MRI
- Signed letter of informed concent
Key exclusion criteria (2 listed)
- Contraindications to MRI
- Previous prostate biopsies
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 |
|---|---|---|
| Cytological imprintsEach targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients | Other | MRI and targeted biopsies |
Primary outcome
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.
Time frame: 15 months
The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard). Measure of agreement, sensitivity and specificity will be calculated.
1 secondary outcome
Interobserver variability
Time frame: 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Eduard Baco, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytological imprints in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Sep 2015. 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 Norway. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The rate of positive and negative cytological imprints, e.g presence of malignant cells or not. (time frame: 15 months). 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 23 Sep 2015.