Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated due to procurement of new funding sources.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The feasibility of outpatient TPM has been well demonstrated.(Bianco & MartÃnez-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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transrectal Ultrasound Guided Biopsy (TRUS) | Active Comparator | Patients will receive a transrectal guided prostate biopsy |
|
| Transperineal Prostate Biopsy | Active Comparator | Patients will receive a transperineal prostate biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prostate biopsy | Procedure | Men will be randomized to receiving either TPM or TRUS targeted biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 7 days post-biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Must have clinical suspicion of prostate cancer
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jim Hu, M.D., M.P.H. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Transrectal Ultrasound Guided Biopsy (TRUS) | Patients will receive a transrectal guided prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy |
| FG001 | Transperineal Prostate Biopsy | Patients will receive a transperineal prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Transrectal Ultrasound Guided Biopsy (TRUS) | Patients will receive a transrectal guided prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy |
| BG001 | Transperineal Prostate Biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| The data was not collected due to the trial being terminated. | Posted | 7 days post-biopsy |
|
Adverse events were not collected.
Adverse event data were not collected due to the trial being terminated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transrectal Ultrasound Guided Biopsy (TRUS) | Patients will receive a transrectal guided prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy |
Not provided
Not provided
Early termination due to procurement of new funding sources.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jim C. Hu | Weill Cornell Medicine | (646) 962-9600 | jch9011@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2018 | Jun 4, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Men will be randomized to receiving either TPM or TRUS targeted biopsy.
Not provided
Not provided
Not provided
Not provided
IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms. |
| 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. | 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. | 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. | initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy |
Patients will receive a transperineal prostate biopsy
prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients will receive a transrectal guided prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy |
| OG001 | Transperineal Prostate Biopsy | Patients will receive a transperineal prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy |
|
| Secondary | 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. | The data was not collected due to the trial being terminated. | Posted | At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy |
|
|
| Secondary | 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. | The data was not collected due to the trial being terminated. | Posted | baseline, 7 days post-biopsy, 30 days post-biopsy |
|
|
| Secondary | 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. | The data was not collected due to the trial being terminated. | Posted | baseline, 7 days post-biopsy, 30 days post-biopsy |
|
|
| Secondary | 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. | The data was not collected due to the trial being terminated. | Posted | baseline, 7 days post-biopsy, 30 days post-biopsy |
|
|
| Secondary | 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. | The data was not collected due to the trial being terminated. | Posted | initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Transperineal Prostate Biopsy | Patients will receive a transperineal prostate biopsy prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |