A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer (CAPTAIN)
S
Shadia Jalal, MD
Primary Investigator
Enrolling By Invitation
40 years - 80 years
Male
Phase
N/A
201 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
The purpose of this research study is to:
- Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy).
- Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure
- Patients will have a 1 in 3 chance of being assigned to the radical prostatectomy group and a 2 in 3 chance of being assigned to the TULSA group. Following treatment, patients will be followed up for 10 years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate Cancer, Prostate Adenocarcinoma
-
Age: 40 years - 80 years
-
Gender: Male
Inclusion Criteria:
- Male
- Age 40 to 80 years, with >10 years life expectancy
- NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
- Stage ≤cT2c, N0, M0
- ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
- PSA ≤20ng/mL within last 3 months
- Treatment-naïve
- Planned ablation volume is < 3 cm axial radius from urethra on mpMRI acquired within last 6 months
Exclusion Criteria:
- Inability to undergo MRI or general anesthesia
- Suspected tumor is > 30 mm from the prostatic urethra
- Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- Artificial urinary sphincter, penile implant, or intraprostatic implant
- Patients who are otherwise not deemed candidates for radical prostatectomy
- Inability or unwillingness to provide informed consent
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
Updated on
01 Aug 2024.
Study ID: UROL-PROFOUND-CAPTAIN, 14890, GCP-10296
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