Prostate CancerNCT02397629
Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
An observational study of Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2016
- Phase
- Observational
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men > 40 years old scheduled for a prostate biopsy
Who may be able to join
- Men age > 40 years
- Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.
- Ability and willingness to sign a written, IRB-approved informed consent document
Who cannot join
- Men using drugs known to interfere with serum PSA or with serum PTHrP and calcium. Drugs known to interfere with PSA include 5-alpha-reductase inhibitors (Proscar). Drugs known to interfere with calcium and/or PTH include lithium and thiazide diuretics.
- Patients with prior transurethral resection of the prostate (TURP) or equivalent procedure (laser incision). In these men the reduction in prostatic volume may give a biased estimate of the relationship between PSA, calcium and PTHrP.
- Patients on dialysis. These are excluded because dialysis increases the percentage of free PSA in serum.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forset University
Winston-Salem, North Carolina, 27157
About this study
This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University.
Read the detailed description
This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University. Men scheduled for biopsy will be approached by the study nurse who will explain the study and invite the men to participate. After the patients provide written consent, she/he will obtain the following information from the patient chart: age, race (self-report, white, black, other), height, weight (for determination of Body Mass Index, a variable reported to influence PSA). Blood draw for study analytes will be coordinated with routine blood draw for PSA testing to minimize the need for an additional needle stick. A copy of the informed consent is given to the patient and the original is placed in a file for the P.I.
The biopsy status of men at the time they are invited to participate is unknown. Men are "sorted" into cancer and non-cancer groups only after their biopsies are read. Serum samples are sent to the Department of Laboratory Medicine at Wake Forest. All assays are performed "in house". Based on consultation with our urologists, we anticipate that approximately 30% of the biopsies will be positive (i.e., prostate cancer). The majority (approximately 70%) will be negative (benign). Approximately 1-2% of the biopsies may be classified as "indeterminate". Because there will not be a sufficient number of "indeterminate" pathologies to be treated as a separate category, this group will not be analyzed further. However, men with "indeterminate" biopsies are eligible for the study if they are re-biopsied.
- Conditions
- Prostate Cancer
- Being tested
- This study has no intervention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study has no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Prostate Biopsy | Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both. Receives: Other: This study has no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 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.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ram Pathak, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397629
- Sponsor's protocol ID
- IRB00014769
- Other IDs
- CCCWFU 85B10
- Status last verified
- Jul 2018
- First submitted
- 17 Mar 2015
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT02397629
- Acronym / sponsor ID
- IRB00014769
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Mar 2015 (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 is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University.
Detailed description
This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University. Men scheduled for biopsy will be approached by the study nurse who will explain the study and invite the men to participate. After the patients provide written consent, she/he will obtain the following information from the patient chart: age, race (self-report, white, black, other), height, weight (for determination of Body Mass Index, a variable reported to influence PSA). Blood draw for study analytes will be coordinated with routine blood draw for PSA testing to minimize the need for an additional needle stick. A copy of the informed consent is given to the patient and the original is placed in a file for the P.I.
The biopsy status of men at the time they are invited to participate is unknown. Men are "sorted" into cancer and non-cancer groups only after their biopsies are read. Serum samples are sent to the Department of Laboratory Medicine at Wake Forest. All assays are performed "in house". Based on consultation with our urologists, we anticipate that approximately 30% of the biopsies will be positive (i.e., prostate cancer). The majority (approximately 70%) will be negative (benign). Approximately 1-2% of the biopsies may be classified as "indeterminate". Because there will not be a sufficient number of "indeterminate" pathologies to be treated as a separate category, this group will not be analyzed further. However, men with "indeterminate" biopsies are eligible for the study if they are re-biopsied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Prostate Biopsy | – | Other: This study has no interventionMen referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men > 40 years old scheduled for a prostate biopsy
Key inclusion criteria (3 listed)
- Men age > 40 years
- Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.
- Ability and willingness to sign a written, IRB-approved informed consent document
Key exclusion criteria (3 listed)
- Men using drugs known to interfere with serum PSA or with serum PTHrP and calcium. Drugs known to interfere with PSA include 5-alpha-reductase inhibitors (Proscar). Drugs known to interfere with calcium and/or PTH include lithium and thiazide diuretics.
- Patients with prior transurethral resection of the prostate (TURP) or equivalent procedure (laser incision). In these men the reduction in prostatic volume may give a biased estimate of the relationship between PSA, calcium and PTHrP.
- Patients on dialysis. These are excluded because dialysis increases the percentage of free PSA in serum.
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 |
|---|---|---|
| This study has no intervention | Other | Patients Undergoing Prostate Biopsy |
Primary outcome
To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy.
Time frame: Day 1
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 11 Mar 2022.
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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.
Ram Pathak, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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: finished, as of the sponsor's last update on 11 Mar 2022. 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 States. 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 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?
To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy. (time frame: Day 1). 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 11 Mar 2022.