UroLift + SAbR for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen ByAurelie Garant, MD
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Texas Southwestern Medical Center
No Placebo Group
Approved in 3 jurisdictions
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.
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.
12345What 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.
34678Is 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.
245910Eligibility 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.
I am older than 45 years.
My urinary symptoms are severe, with an AUA score of 17 or more.
My prostate cancer is early stage, not spread, with specific Gleason scores.
My prostate is smaller than 100 grams, as measured by ultrasound or MRI.
My health is good to moderately impaired.
I can be safely put under general anesthesia for less than an hour.
Exclusion Criteria
I have had treatments like radiotherapy, chemotherapy, or surgery for prostate cancer.
I don't have urethral conditions that would prevent UroLift System procedures.
I am currently on hormone therapy for cancer.
I have urinary incontinence because of a weak bladder sphincter.
I currently have a urinary tract infection.
I have had surgery or procedures for an enlarged prostate.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: All Study participantsExperimental Treatment2 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:
πͺπΊ Approved in European Union as SABR/SBRT for:
- Low-risk prostate cancer
- Intermediate-risk prostate cancer
- High-risk prostate cancer
πΊπΈ Approved in United States as SABR/SBRT for:
- Low-risk prostate cancer
- Intermediate-risk prostate cancer
- High-risk prostate cancer
- Recurrent prostate cancer
π¬π§ Approved in United Kingdom as SABR/SBRT for:
- Low-risk prostate cancer
- Intermediate-risk prostate cancer
- High-risk prostate cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Texas Southwestern Medical Center - DallasDallas, TX
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
NeoTract, Inc.Industry Sponsor
References
Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]Stereotactic ablative radiotherapy (SABR) is appealing for prostate cancer (PCa) due to low Ξ±/Ξ², and increasing the dose per fraction could improve the therapeutic index and lead to a better quality of life (QOL). Here we report the outcomes of a QOL comparison between two phase II clinical trials: two vs. five fraction prostate SABR.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available.
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy. Optimal doses remain poorly defined with limited prospective comparative trials and long-term safety/efficacy data at higher dose levels. We analyzed toxicity and outcomes for SAbR in men with localized PCa at escalated 45 Gy in 5 fractions.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]There are no safety-focused trials on stereotactic body radiotherapy (SBRT) for localized prostate cancer. This prospective 3βyear phase II trial used binomial law to validate the safety and efficacy of SBRT with stringent organ at risk dose constraints that nevertheless permitted high planning target volume doses.
Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]The safety and efficacy of stereotactic body radiotherapy (SBRT) in localised prostate cancer are now established through phase III randomised trials. Its utility in node-positive prostate cancer is restricted due to a lack of controlled studies specifically addressing this subgroup. Herein we report the safety and efficacy of SBRT in this subgroup.
Cyberknife Radioablation of Prostate Cancer β Preliminary Results for 400 Patients [2020]Objectives: To evaluate the tolerance and effectiveness of stereotactic ablative radiotherapy (SABR) applied in the treatment of low and intermediate risk (LR & IR) prostate cancer patients (PCP) and provide an evaluation of the level of risk group impact on treatment results. In addition, androgen deprivation therapy (ADT) usage and prostatic specific antigen (PSA) decline after SABR were assessed. Material and Methods: A total of 400 PCP (213 LR and 187 IR, including T2c) were irradiated with a CyberKnife using fd 7.25 Gy to TD 36.25 Gy. At the start of treatment, 60.3% of patients were undergoing ADT and this gradually decreased to 0% after 38 months. Follow-up was for a median of 15.0 months. Patients were monitored on SABR completion and 1, 4, 8 months later and then subsequently every 6 months. GI (Gastro-Intestinal) and GU (Genito-Urinary) acute and late adverse effects, PSA and ADT usage were evaluated. Results: Failure was noted in 9 patients (2.25%) (5 in LR and 4 in IR groups) - 4 relapses and 5 nodal metastases. No G3/4 late adverse effects (EORTC/RTOG) were observed. Some 0.5% of G3 GU and 0.3% of G3 GI acute reactions were noted respectively on the SABR completion day and one month later. The median of PSA declined 1.5 ng/ml during the first month and 0.6 ng/ml during the next three months. No impact of risk groups on treatment results was found. An impact of ADT on PSA decline was only confirmed for time point interactions. Conclusions: SABR for LR and IR PCP is a safe and effective treatment. The inclusion of T2c patients and the low percentage of IR patient failure permit us the assumption that this procedure could be utilized in the treatment of more advanced cases. The results do not allow clear definition of the impact of ADT on radioablation results in LR and IR+ T2c cases.
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]To present the 18 months results from a prospective multicenter phase II randomized trial of short vs protracted urethra-sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer (PCa).
Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]Prostate is the most common non-cutaneous cancer diagnosed among men in North America. Fortunately most prostate cancers are screen detected and non-metastatic on diagnosis. Treatment options for men with localized prostate cancer include surgery Β± postoperative radiation or radiation Β± androgen deprivation therapy (ADT). Brachytherapy Β± external beam radiation treatment (EBRT) appears to have superior long-term disease control over EBRT alone likely because of higher biologic effective dose delivered. Stereotactic ablative body radiation (SABR) is a novel, non-invasive, high-precision EBRT technique that allows safe delivery of biologic doses similar to brachytherapy with similar or lower side effects [measured using toxicity or quality of life (QOL) scales]. 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 and incidence of metastases. SABR dose escalation reduces biopsy positivity and prostate-specific antigen (PSA) nadirs but increases genitourinary (GU) and gastrointestinal (GI) toxicity-no effect on BF has been realized yet. The overall treatment time (OTT) varies in many protocols. Phase 2 randomized data shows that QOL is better in the acute setting with a weekly course of treatment compared to an every other day treatment regimen with no difference in late setting. Follow-up data are immature and likely underpowered to determine efficacy differences. SABR is cheaper and uses less resource than any other radiation technique. Given the healthcare resource challenges (including financial resources), SABR would be a welcomed addition if studies show non-inferiority to other radiation techniques. For patients with de novo or metastatic disease on relapse, there is much enthusiasm regarding the use of SABR in the setting of oligometastatic prostate cancer. SABR appears to be feasible to deliver, well tolerated and may delay the next line of therapy. However, until adequately powered randomized studies confirm a benefit, such an approach cannot be considered standard of care treatment at this time. Enrollment of eligible prostate cancer patients onto SABR clinical trials should be encouraged.