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UroLift System With SAbR for Prostate Cancer and BPH

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Urolift

SABR

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

AJCC 8th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland, Gleason 3+3 = 6 or 3+4 = 7, with no direct evidence of regional or distant metastases following appropriate staging studies. See Appendix I for details on AJCC 8th Edition staging criteria. T-staging may be assessed by multi-parametric imaging alone if digital rectal examination was deferred
Histologic confirmation of prostate cancer is required by biopsy performed within 18 months of registration.
Age > 45 years.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
American Society of Anesthesia (ASA) physical status score of 1-3
Baseline AUA symptom score ≥ 17 regardless of medical therapy
The serum PSA should be < 20 ng/ml within 120 days of registration
Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT or anti-androgen therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride; (5) within 5 days of a digital rectal examination
Ultrasound or MRI based volume estimation of prostate gland < 100 grams, regardless of cytoreduction with pharmacotherapy
Ability to undergo general anesthesia for <60 minutes
Ability to understand and the willingness to sign a written informed consent.
All men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria:

Contraindications to UroLift System placement including:
Prostate volume >100 cc based on imaging-based estimation
Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion of UroLift System delivery system into the bladder
Urinary incontinence due to incompetent sphincter
An active urinary tract infection
Current gross hematuria
In addition to the contraindications if there is a known allergy to nickel, titanium, or stainless steel these patients should be excluded
Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple prostatectomy, or other ablative procedures for benign prostatic hyperplasia.
Foley / self-catheterization in the last 12 months.
Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7, clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy cores positive for cancer are ineligible.
Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.
Current active androgen deprivation therapy

Sites / Locations

University of Texas Southwestern Medical Center - DallasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Study participants

Arm Description

Study participants will undergo Urolift System followed by SABR

Outcomes

Primary Outcome Measures

Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia

Analyses will be performed for all subjects having received at least one fraction of radiation therapy. The study will use CTCAE version 5.0 for reporting of adverse events and, for reporting purposes, will also capture Clavien-Dindo grading system for the classification of surgical complications for reporting adverse events related to the UroLift System procedure.

Secondary Outcome Measures

Quality of Life with UroLift System

AUA, EPIC-26 questionnaires and Noninvasive urodynamics will be obtained, these data will be analyzed once all patients have completed the scheduled trial visits.The aggregate score will be done for (urinary, sexual, bowel, and health-related) associated with UroLift System when administered prior to SABR.

Full Information

NCT ID

NCT05311527

First Posted

March 15, 2022

Last Updated

January 27, 2023

Sponsor

University of Texas Southwestern Medical Center

Collaborators

NeoTract, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05311527

Brief Title

UroLift System With SAbR for Prostate Cancer and BPH

Official Title

Using UroLift System With Stereotactic Ablative Body Radiotherapy For Men With Prostate Cancer and Benign Prostatic Hyperplasia (BPH): a Phase I Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2023 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

NeoTract, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)

Detailed Description

UroLift System implant will be implanted transurethrally under cystoscopic guidance with a UroLift System Delivery Device by a trained provider. Optimal placement of the implants will be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted but more or less can be placed per provided discretion, up to a maximum of 10 implants per manufacturer specifications. Given that patients will also undergo UroLift System placement, patients will be offered to undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one single procedure, under general anesthesia. SAbR will be performed following placement of UroLift System, prostate fiducials, rectal spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema, prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder filling protocol, and appropriate imaging verification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Non-blinded

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All Study participants

Arm Type

Experimental

Arm Description

Study participants will undergo Urolift System followed by SABR

Intervention Type

Device

Intervention Name(s)

Urolift

Intervention Description

Urolift Implant

Intervention Type

Radiation

Intervention Name(s)

SABR

Other Intervention Name(s)

SBRT

Intervention Description

Stereotactic Body Radiation Therapy for prostate cancer

Primary Outcome Measure Information:

Title

Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia

Description

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Quality of Life with UroLift System

Description

Time Frame

90 days

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: AJCC 8th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland, Gleason 3+3 = 6 or 3+4 = 7, with no direct evidence of regional or distant metastases following appropriate staging studies. See Appendix I for details on AJCC 8th Edition staging criteria. T-staging may be assessed by multi-parametric imaging alone if digital rectal examination was deferred Histologic confirmation of prostate cancer is required by biopsy performed within 18 months of registration. Age > 45 years. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1. American Society of Anesthesia (ASA) physical status score of 1-3 Baseline AUA symptom score ≥ 17 regardless of medical therapy The serum PSA should be < 20 ng/ml within 120 days of registration Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT or anti-androgen therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride; (5) within 5 days of a digital rectal examination Ultrasound or MRI based volume estimation of prostate gland < 100 grams, regardless of cytoreduction with pharmacotherapy Ability to undergo general anesthesia for <60 minutes Ability to understand and the willingness to sign a written informed consent. All men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria: Contraindications to UroLift System placement including: Prostate volume >100 cc based on imaging-based estimation Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion of UroLift System delivery system into the bladder Urinary incontinence due to incompetent sphincter An active urinary tract infection Current gross hematuria In addition to the contraindications if there is a known allergy to nickel, titanium, or stainless steel these patients should be excluded Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple prostatectomy, or other ablative procedures for benign prostatic hyperplasia. Foley / self-catheterization in the last 12 months. Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7, clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy cores positive for cancer are ineligible. Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer. Current active androgen deprivation therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonobia Garrett, MS

Phone

12146458787

sonobia.garrett@utsouthwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jose Santoyo

Phone

214-645-8764

jose.santoyo@utsouthwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aurelie Garant, MD

Organizational Affiliation

University of Texas Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern Medical Center - Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

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UroLift System With SAbR for Prostate Cancer and BPH

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