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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of using the UroLift System alongside Stereotactic Ablative Radiotherapy (SAbR) to treat prostate cancer. The researchers aim to assess the safety of this combination, particularly in men with both prostate cancer and benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate. They will measure any complications occurring within 90 days after treatment. Men diagnosed with prostate cancer, who have a history of BPH, and experience urinary problems requiring medical treatment may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment options for prostate cancer patients with BPH.

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 prior data suggests that combining the UroLift System with SAbR is safe for prostate cancer patients with BPH?

Research has shown that the UroLift System is generally safe for treating an enlarged prostate. In one study, patients experienced quick relief and stable results for up to a year. Another study over five years found that few patients needed additional treatment, suggesting the procedure's reliability.

For Stereotactic Ablative Radiotherapy (SABR), research indicates it is well-tolerated by patients with prostate cancer. One study found that specific doses of SABR led to minimal side effects, suggesting it is a safe treatment option for prostate cancer.

Both treatments have demonstrated promising safety records in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of UroLift and Stereotactic Ablative Radiotherapy (SABR) for prostate cancer because it offers a unique approach by integrating a minimally invasive procedure with precise radiation therapy. Unlike traditional prostate cancer treatments, which often involve surgery or prolonged radiation courses, UroLift helps relieve urinary symptoms by lifting and holding the enlarged prostate tissue out of the way, enabling SABR to target the cancer more effectively. This method has the potential to reduce treatment time and side effects, making it a promising option for patients seeking less invasive and more efficient alternatives.

What evidence suggests that combining UroLift with SAbR could be effective for prostate cancer?

Research has shown that the UroLift System can quickly and effectively ease symptoms of an enlarged prostate. Studies indicate that patients notice improvement in urinary symptoms within two weeks, with benefits lasting at least a year. Meanwhile, Stereotactic Ablative Radiotherapy (SABR) has proven to control prostate cancer effectively over the long term. It is well-tolerated, even in high-risk patients, and helps reduce cancer symptoms. In this trial, participants will undergo the UroLift System followed by SABR, combining the benefits of both treatments for managing prostate issues. ^{1 2 3 6 7}

Who Is on the Research Team?

Aurelie Garant, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043737/

Stereotactic ablative body radiotherapy in patients with ... Efficacy for SABR appears to be similar to brachytherapy including positive biopsy rates 2–3 years post treatment, biochemical failure (BF) rates out to 10-year ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850025001511

Clinician- and Patient-Reported Outcomes of Stereotactic ... Conclusions. SABR delivering 40 Gy in 5 fractions is feasible and well-tolerated for high-risk prostate cancer, with minimal additional toxicity ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2763312

Outcomes of Observation vs Stereotactic Ablative ... Conclusions and Relevance Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of ...

4. redjournal.org redjournal.org/article/S0360-3016(24)03368-6/abstract

Stereotactic Radiation Therapy for Localized Prostate Cancer Conclusions. SABR shows excellent long-term disease control for low- and intermediate-risk localized prostate cancer. Patients treated for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06325046?term=John

Adaptive Radiation Therapy (ART) Stereotactic Ablative ... Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6484596/

Long-term Outcomes of Stereotactic Body Radiotherapy for ... Comparative analysis of efficacy and safety of radiation treatment options for low- and intermediate-risk prostate cancer.

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.779182/full

Dose-Intensified Stereotactic Ablative Radiation for ... Dose escalation in multiple studies has shown improved BFFS in patients treated with escalating SAbR doses of 40 Gy or higher in 5 fractions ...