UroLift + SAbR for Prostate Cancer

Overseen By Jose Santoyo

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Prostate volume >100 cc, Urethral conditions, Urinary incontinence, Active UTI, Gross hematuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial combines the UroLift System, which helps men with an enlarged prostate by opening up the urinary passage, with a precise radiation treatment for prostate cancer. It targets men who have both conditions to improve their treatment outcomes. The UroLift System is a minimally invasive treatment designed to improve lower urinary tract symptoms in men with an enlarged prostate without affecting sexual function.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy, you cannot participate in the trial. Also, certain medications like finasteride and dutasteride have specific time frames for PSA testing, which might affect your eligibility.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that PSA tests should not be done within certain time frames after stopping medications like finasteride or dutasteride, which might suggest some medications could be relevant to the study.

What data supports the idea that UroLift + SAbR for Prostate Cancer is an effective treatment?

The available research shows that Stereotactic Ablative Radiotherapy (SABR) is promising for treating prostate cancer. Studies have found that SABR can improve the quality of life for patients, as it involves fewer treatment sessions compared to traditional methods. This makes it more convenient and potentially less costly. Additionally, SABR has been shown to be effective for different stages of prostate cancer, including localized and more advanced cases. However, there is limited information specifically about the combination of UroLift and SABR, so more research might be needed to fully understand its effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment UroLift + SAbR for Prostate Cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR) is promising for treating prostate cancer, with studies indicating it can improve quality of life and is effective for both localized and advanced cases. However, specific data on combining SABR with the UroLift system for prostate cancer is not directly available. ^{1 2 3 4 5}

What safety data exists for UroLift + SAbR in prostate cancer treatment?

The safety of Stereotactic Ablative Radiotherapy (SABR) for prostate cancer has been evaluated in several studies. SABR, also known as Stereotactic Body Radiation Therapy (SBRT), has shown promising safety results in treating low to intermediate-risk prostate cancer. A study involving 400 patients treated with SABR using the CyberKnife system reported no Grade 3 or 4 late adverse effects, with only minor acute reactions observed. Another study confirmed the safety of SBRT with stringent dose constraints for localized prostate cancer. However, there is limited data on the combination of UroLift and SABR specifically, as most studies focus on SABR alone. Further research is needed to evaluate the safety of this combined treatment approach. ^{3 4 6 7 8}

Is the combination of UroLift and SAbR safe for treating prostate cancer?

Stereotactic Ablative Radiotherapy (SAbR) has been shown to be generally safe for treating prostate cancer, with studies reporting low rates of severe side effects. The UroLift procedure, used for benign prostatic hyperplasia, is also considered safe, but specific safety data for the combination of UroLift and SAbR in prostate cancer treatment is not available. ^{3 4 6 7 8}

Is the treatment Stereotactic Ablative Radiotherapy (SABR) promising for prostate cancer?

Yes, SABR is a promising treatment for prostate cancer. It is a non-invasive, high-precision radiation therapy that can deliver effective doses similar to other treatments with fewer side effects. It is also cheaper and uses fewer resources, making it a valuable option in healthcare. Early results show it is well-tolerated and may delay further treatment needs. ^{2 4 5 9 10}

How is the UroLift + SAbR treatment for prostate cancer different from other treatments?

The UroLift + SAbR treatment is unique because it combines a minimally invasive procedure (UroLift) with a high-precision radiation therapy (SABR) that delivers high doses of radiation directly to the prostate cancer, potentially offering similar effectiveness to traditional brachytherapy but with fewer side effects and a shorter treatment time. ^{2 4 5 9 10}

Research Team

Aurelie Garant, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

Men over 45 with early-stage prostate cancer and BPH, ECOG status 0-1, ASA score of 1-3. PSA <20 ng/ml, willing to use contraception. No prior prostate treatments or active infections; no urinary incontinence or conditions preventing UroLift insertion.

Inclusion Criteria

I am fully active or can carry out light work.

My prostate cancer was confirmed by a biopsy within the last 18 months.

I am older than 45 years.

Exclusion Criteria

I have had treatments like radiotherapy, chemotherapy, or surgery for prostate cancer.

You cannot have the UroLift System placed if you have:

I don't have urethral conditions that would prevent UroLift System procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

UroLift System Placement

UroLift System implant is placed transurethrally under cystoscopic guidance, along with fiducial marker and rectal gel spacer placement under general anesthesia

1 day

1 visit (in-person)

Stereotactic Ablative Body Radiotherapy (SAbR)

SAbR is performed following placement of UroLift System, prostate fiducials, and rectal spacer, with stereotactic immobilization/localization and imaging verification

Up to 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including analysis of adverse events and quality of life assessments

90 days

Treatment Details

Interventions

• Stereotactic Ablative Radiotherapy (SABR)
• UroLift System

Trial Overview The trial tests the safety of using the UroLift System before Stereotactic Ablative Radiotherapy (SAbR) in men with newly diagnosed prostate cancer who also have BPH by monitoring complications within 90 days post-treatment.

Participant Groups

Group I: All Study participants Experimental Treatment 2 Interventions

Study participants will undergo Urolift System followed by SABR

Stereotactic Ablative Radiotherapy (SABR) is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Approved in United States as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer
• Recurrent prostate cancer

Approved in United Kingdom as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

NeoTract, Inc.

Industry Sponsor

Trials

11

Recruited

3,400+

Findings from Research

In a study comparing two different fractionation schedules of stereotactic ablative radiotherapy (SABR) for prostate cancer, the 2-fraction treatment (26 Gy/2) showed significantly better quality of life (QOL) outcomes in the bowel domain compared to the 5-fraction treatment (40 Gy/5), with a lower rate of clinically important changes in bowel function.

Both treatment groups had low five-year biochemical failure rates (3.3% for 2-fraction and 4.6% for 5-fraction), indicating that the 2-fraction SABR is not only effective but also well tolerated, warranting further randomized trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. Alayed, Y., Quon, H., Cheung, P., et al.[2020]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

Stereotactic ablative radiotherapy (SABR) is a safe and effective treatment for low and intermediate risk prostate cancer, with only a 2.25% failure rate observed in a study of 400 patients over a median follow-up of 15 months.

The treatment resulted in a significant decline in prostate-specific antigen (PSA) levels, with no severe late adverse effects reported, indicating that SABR could be considered for more advanced cases of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients Miszczyk, L., Namysł Kaletka, A., Napieralska, A., et al.[2020]

In a study of 170 prostate cancer patients, urethra-sparing stereotactic body radiotherapy (SBRT) demonstrated a low toxicity profile, with less than 5% experiencing grade 2 or higher genitourinary and less than 2% gastrointestinal toxicity at 18 months.

Both treatment schedules (every other day and once a week) resulted in favorable biochemical control rates, with only four cases of biochemical failure, indicating that the treatment is effective regardless of the frequency of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results. Zilli, T., Jorcano, S., Bral, S., et al.[2021]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

5. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

8. Thailand pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results. [2021]

10. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]