Prostate CancerPhase 1NCT02747563
Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination
A Phase 1 study testing Blood test (PSA) in people with Prostate Cancer, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Blood test (PSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to May 2017
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males
- Intact Rectum
- Prostate Cancer eligible for active surveillance
Who cannot join
- Pror radiation therapy
- Under Androgen Deprivation Therapy
- Prior prostate surgery
Trial locations and contacts
1 site in 1 country.
Uri Lindner, M.D. contact
Israel1 site
Kaplan Medical Center
Rehovot
Uri Lindner, M.D., urili@clalit.org.il
About this study
Official title: Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination
Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination
Read the detailed description
Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA < 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination.
The change of PSA will be evaluated.
- Conditions
- Prostate Cancer
- Being tested
- Blood test (PSA)
- Keywords
- prostate cancer, PSA, digital rectal examination
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test (PSA)Other
Measurement of blood PSA levels
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Experimental | Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement Receives: Other: Blood test (PSA) |
| Controls | Active comparator | Patients without known diagnosis of prostate cancer Intervention - PSA measurement Receives: Other: Blood test (PSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of PSA elevation after DRE
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Uri Lindner, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747563
- Sponsor's protocol ID
- 0210-15-KMC
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination
- ClinicalTrials.gov ID
- NCT02747563
- Acronym / sponsor ID
- 0210-15-KMC
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, PSA, digital rectal examination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 21 Apr 2016 (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.
Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination
Detailed description
Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA < 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination.
The change of PSA will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Experimental | Other: Blood test (PSA)Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement |
| Controls | Active comparator | Other: Blood test (PSA)Patients without known diagnosis of prostate cancer Intervention - PSA measurement |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males
- Intact Rectum
- Prostate Cancer eligible for active surveillance
Key exclusion criteria (3 listed)
- Pror radiation therapy
- Under Androgen Deprivation Therapy
- Prior prostate surgery
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 |
|---|---|---|
| Blood test (PSA)Measurement of blood PSA levels | Other | Active Surveillance, Controls |
Primary outcome
Percentage of PSA elevation after DRE
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Uri Lindner, M.D. contact
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 Blood test (PSA) in people with Prostate Cancer, run by Kaplan Medical Center at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Apr 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Lindner, M.D. (urili@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of PSA elevation after DRE (time frame: 1 hour). 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 21 Apr 2016.