Prostate CancerNCT03632655
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches
A study testing prostate biopsy in people with Prostate Cancer and Elevated PSA, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Elevated PSA
- What is being tested?
- prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2017to 8 Oct 2020
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 18 years or older with suspicion for prostate cancer based upon an elevated PSA, abnormal digital rectal examination, abnormal MRI
- Men on active surveillance with indication for biopsy
Who cannot join
- Men with active urinary tract infection, metastatic prostate cancer, history of colorectal surgery limiting insertion of transrectal probe, evidence of acute or chronic prostatitis, or concern for perineal cellulitis or fistula
- Men unfit to undergo prostate biopsy under local anesthesia
- Men with prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- Men with contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.
Read the detailed description
The feasibility of outpatient TPM has been well demonstrated.(Bianco \& Martínez-Salamanca, 2016; Merrick et al., 2016; Smith et al., 2014) New technology now allows for fusion of MRI images with TPM devices, allowing for targeting of cancerous-appearing lesions on MRI. Such technology that fuses MRI-imaging with TRUS biopsy has become routine in U.S. clinical practice, with improved cancer detection rates as compared with standard TRUS.(Ahmed et al., 2017; Robertson, Emberton, \& Moore, 2013)
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Men will be randomized to receiving either TPM or TRUS targeted biopsy. All men will receive a urine culture within 2 weeks of biopsy and will be started on antibiotic prophylaxis prior to biopsy in accordance with AUA antimicrobial prophylaxis guidelines. Men with a positive urine culture will be treated with culture-specific antibiotics and must have a documented negative urine culture prior to biopsy.
- Conditions
- Prostate Cancer, Elevated PSA
- Being tested
- 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.
prostate biopsyProcedure or surgery
Men will be randomized to receiving either TPM or TRUS targeted biopsy
| Study group | Role | What they receive |
|---|---|---|
| Transrectal Ultrasound Guided Biopsy (TRUS) | Active comparator | Patients will receive a transrectal guided prostate biopsy Receives: Procedure: prostate biopsy |
| Transperineal Prostate Biopsy | Active comparator | Patients will receive a transperineal prostate biopsy Receives: Procedure: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gleason Grade
Detection of clinically significant disease
Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.
- Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly.
- A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread.
- Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.
Measured: 7 days post-biopsy
Secondary outcomes (5)
Patient-reported Pain, as Measured on a 0-10 Likert Scale
Pain will be scored on a 0-10 Likert scale. 0 indicates no pain and high scores indicate greater pain.
Measured: At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy
Patient-reported Symptoms, as Measured by International Prostate Symptom Scores (IPSS) Questionnaire
IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
Measured: baseline, 7 days post-biopsy, 30 days post-biopsy
Patient-reported Erectile Function, as Measured by International Index of Erectile Function (IIEF-5) Questionnaire
IIEF-5 scores range from 1 to 25, with 1-7 indicating severe erectile dysfunction, 8-11 indicating moderate erectile dysfunction, 12-16 indicating mild-moderate erectile dysfunction, 17-21 indicating mild erectile dysfunction, and 22-25 indicating no erectile dysfunction.
Measured: baseline, 7 days post-biopsy, 30 days post-biopsy
Patient-reported Quality of Life, as Measured by EPIC-CP Questionnaire
EPIC-CP comprises of 10 questions about the patient within the last four weeks.
Questions 1,7,8,9 are each graded on a scale from 0-4 for a total of 12 points. Higher scores indicate worse quality of life with regards to urinary and sexual function.
Questions 2-4 grade Urinary Incontinence Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse urinary incontinence symptoms.
Questions 5a-c grade Urinary Irritation/Obstructive Symptoms on a scale from 0-4 (max 12 poitns). Higher scores indicate worse urinary irritation/obstructive symptoms.
Questions 6a-c grade Bowel Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse bowel symptoms.
Questions 10a-c grade Vitality/Hormonal Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse vitality/hormonal symptoms.
All scores are summed (max 60 points) to calculate the Overall Prostate Cancer QOL score. Higher score indicates worse patient-reported QOL.
Measured: baseline, 7 days post-biopsy, 30 days post-biopsy
Adverse Events
Adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, hematochezia, and/or infection.
Measured: initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start23 Dec 2017
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Why it stopped: The study was terminated due to procurement of new funding sources.
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Men will be randomized to receiving either TPM or TRUS targeted biopsy.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jim Hu, M.D., M.P.H., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632655
- Sponsor's protocol ID
- 1705018187
- Status last verified
- May 2024
- First submitted
- 9 Aug 2018
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches: Transrectal Ultrasound-guided Biopsy Compared With a Transperineal Approach
- ClinicalTrials.gov ID
- NCT03632655
- Acronym / sponsor ID
- 1705018187
- Conditions
- Prostate Cancer, Elevated PSA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to procurement of new funding sources.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.
Detailed description
The feasibility of outpatient TPM has been well demonstrated.(Bianco \& Martínez-Salamanca, 2016; Merrick et al., 2016; Smith et al., 2014) New technology now allows for fusion of MRI images with TPM devices, allowing for targeting of cancerous-appearing lesions on MRI. Such technology that fuses MRI-imaging with TRUS biopsy has become routine in U.S. clinical practice, with improved cancer detection rates as compared with standard TRUS.(Ahmed et al., 2017; Robertson, Emberton, \& Moore, 2013)
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Men will be randomized to receiving either TPM or TRUS targeted biopsy. All men will receive a urine culture within 2 weeks of biopsy and will be started on antibiotic prophylaxis prior to biopsy in accordance with AUA antimicrobial prophylaxis guidelines. Men with a positive urine culture will be treated with culture-specific antibiotics and must have a documented negative urine culture prior to biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Men will be randomized to receiving either TPM or TRUS targeted biopsy.
| Arm | Type | Receives |
|---|---|---|
| Transrectal Ultrasound Guided Biopsy (TRUS) | Active comparator | Procedure: prostate biopsyPatients will receive a transrectal guided prostate biopsy |
| Transperineal Prostate Biopsy | Active comparator | Procedure: prostate biopsyPatients will receive a transperineal prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men 18 years or older with suspicion for prostate cancer based upon an elevated PSA, abnormal digital rectal examination, abnormal MRI
- Men on active surveillance with indication for biopsy
Key exclusion criteria (4 listed)
- Men with active urinary tract infection, metastatic prostate cancer, history of colorectal surgery limiting insertion of transrectal probe, evidence of acute or chronic prostatitis, or concern for perineal cellulitis or fistula
- Men unfit to undergo prostate biopsy under local anesthesia
- Men with prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- Men with contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
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 |
|---|---|---|
| prostate biopsyMen will be randomized to receiving either TPM or TRUS targeted biopsy | Procedure or surgery | Transperineal Prostate Biopsy, Transrectal Ultrasound Guided Biopsy (TRUS) |
Primary outcome
Gleason Grade
Time frame: 7 days post-biopsy
Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. * Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. * A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread. * Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.
5 secondary outcomes
Patient-reported Pain, as Measured on a 0-10 Likert Scale
Time frame: At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy
Patient-reported Symptoms, as Measured by International Prostate Symptom Scores (IPSS) Questionnaire
Time frame: baseline, 7 days post-biopsy, 30 days post-biopsy
Patient-reported Erectile Function, as Measured by International Index of Erectile Function (IIEF-5) Questionnaire
Time frame: baseline, 7 days post-biopsy, 30 days post-biopsy
Patient-reported Quality of Life, as Measured by EPIC-CP Questionnaire
Time frame: baseline, 7 days post-biopsy, 30 days post-biopsy
Adverse Events
Time frame: initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
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.
Jim Hu, M.D., M.P.H. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostate biopsy in people with Prostate Cancer and Elevated PSA, run by Weill Medical College of Cornell University 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 2 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: stopped early, as of the sponsor's last update on 31 May 2024. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2021). 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?
Gleason Grade (time frame: 7 days post-biopsy). 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 31 May 2024.