Prostate CancerPhase 4NCT01296672
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
A Phase 4 study testing Finasteride in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 383 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2
- Patient has been recommended to undergo and plans to have a prostate biopsy.
- Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
- No allergy to finasteride or other five alpha reductase inhibitors.
- Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
- Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)
Who cannot join
- Risk of cancer greater than 60% or less than 20%.
- Prior history of prostate cancer.
- Prior treatment with finasteride or dutasteride in the past 6 months
- Younger than age 55.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio, Texas, 78229
About this study
Official title: Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.
Read the detailed description
The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.
- Conditions
- Prostate Cancer
- Being tested
- Finasteride, Placebo
- Keywords
- Finasteride, Placebo, Prostate cancer, Prostate Specific Antigen (PSA), Men at intermediate risk of prostate cancer, Men scheduled for prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinasterideDrug
Also called Proscar®, Propecia®
Finasteride 5mg every day by mouth for 3 months
PlaceboDrug
Placebo every day by mouth for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Finasteride | Experimental | Finasteride 5mg tablets every day by mouth for 3 months Receives: Drug: Finasteride |
| Placebo | Placebo comparator | Placebo 5mg tablet every day by mouth for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre/Post Ratio PSA Area Under the Curve (AUC)
Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
Measured: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
Secondary outcomes (2)
PCA3 (Prostate Cancer Antigen 3)Score AUC
Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
Measured: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer
Measured: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Javier Hernandez, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296672
- Sponsor's protocol ID
- ROI 10-352H
- Other IDs
- R01CA138627
- Status last verified
- Mar 2017
- First submitted
- 3 Feb 2011
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hernandez J, Gelfond J, Goros M, Liss MA, Liang Y, Ankerst D, Thompson IM Jr, Leach RJ. The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial. PLoS One. 2018 Oct 9;13(10):e0204823. doi: 10.1371/journal.pone.0204823. eCollection 2018.
PubMed 30300367
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
- ClinicalTrials.gov ID
- NCT01296672
- Acronym / sponsor ID
- ROI 10-352H
- Conditions
- Prostate Cancer
- Keywords
- Finasteride, Placebo, Prostate cancer, Prostate Specific Antigen (PSA), Men at intermediate risk of prostate cancer, Men scheduled for prostate biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Posted 8 Sep 2017
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 propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.
Detailed description
The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finasteride | Experimental | Drug: FinasterideFinasteride 5mg tablets every day by mouth for 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 5mg tablet every day by mouth for 3 months |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2
- Patient has been recommended to undergo and plans to have a prostate biopsy.
- Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
- No allergy to finasteride or other five alpha reductase inhibitors.
- Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
Key exclusion criteria (4 listed)
- Risk of cancer greater than 60% or less than 20%.
- Prior history of prostate cancer.
- Prior treatment with finasteride or dutasteride in the past 6 months
- Younger than age 55.
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 |
|---|---|---|
| FinasterideAlso: Proscar®, Propecia®Finasteride 5mg every day by mouth for 3 months | Drug | Finasteride |
| PlaceboPlacebo every day by mouth for 3 months | Drug | Placebo |
Primary outcome
Pre/Post Ratio PSA Area Under the Curve (AUC)
Time frame: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
2 secondary outcomes
PCA3 (Prostate Cancer Antigen 3)Score AUC
Time frame: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
Time frame: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30300367Hernandez J, Gelfond J, Goros M, Liss MA, Liang Y, Ankerst D, Thompson IM Jr, Leach RJ. The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial. PLoS One. 2018 Oct 9;13(10):e0204823. doi: 10.1371/journal.pone.0204823. eCollection 2018.
Related trials for Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 3
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
RecruitingPhase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
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.
Javier Hernandez, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finasteride in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio 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 6 inclusion and 4 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 Oct 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre/Post Ratio PSA Area Under the Curve (AUC) (time frame: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296672, which also lists 1 linked publication.
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 Oct 2017.