Neurovascular Sparing Radiotherapy for Prostate Cancer
(VORTEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to using radiation therapy for prostate cancer, aiming to protect the nerves and blood vessels crucial for sexual function. It compares two radiation delivery methods: one adapts the treatment plan daily based on MRI images, and the other does not. The goal is to determine if the adaptive method can reduce side effects such as urinary, bowel, and sexual issues. Men diagnosed with localized prostate cancer who have not undergone certain treatments may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in prostate cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this neurovascular sparing technique is safe for prostate cancer patients?
Research shows that stereotactic body radiotherapy (SBRT) is generally safe for treating prostate cancer. It is a common, low-risk procedure used in many cancer treatments. Studies have demonstrated that SBRT can effectively target cancer while sparing important areas like the nerves and blood vessels crucial for sexual function.
One study found that patients who received SBRT for prostate cancer had similar long-term results whether treated every other day or on consecutive days, suggesting the treatment is well-tolerated. However, some patients may experience issues with urinary and bowel functions or sexual health after radiation therapy.
Overall, the safety profile of SBRT is favorable, especially since it is already used to treat other conditions. The trial's phase indicates that SBRT has been tested in many patients, adding to the evidence of its safety for humans.12345Why are researchers excited about this trial?
Researchers are excited about neurovascular sparing stereotactic body radiation therapy (SBRT) for prostate cancer because it offers a more precise approach to targeting tumors while minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapies, which can affect nearby organs and nerves, this treatment uses MRI or CT guidance with daily plan adaptation, allowing it to adjust for changes in the patient's anatomy and tumor position. This approach aims to maintain the patient's quality of life by reducing side effects, such as urinary and sexual dysfunction, which are common with standard radiation treatments. Additionally, the therapy is completed in just five sessions over 18 days, potentially offering a more convenient and less disruptive option for patients.
What evidence suggests that neurovascular sparing stereotactic body radiation therapy is effective for prostate cancer?
Research has shown that stereotactic body radiotherapy (SBRT) is a promising treatment for localized prostate cancer. It delivers high doses of radiation directly to the cancer, helping to control the disease. Studies have found that about 88.6% of patients treated with SBRT did not experience disease progression after three years. In this trial, participants will join one of two treatment arms: Arm 1 involves non-adaptive SBRT, while Arm 2 involves neurovascular sparing SBRT with daily plan adaptation. The neurovascular sparing technique aims to protect nerves and blood vessels crucial for sexual function, potentially maintaining quality of life. However, improvements in sexual function have been inconsistent, with erectile dysfunction rates still ranging from 40% to 67% in some cases. Overall, SBRT remains a promising approach, with ongoing research to enhance its benefits while reducing side effects.12367
Who Is on the Research Team?
Amar Kishan, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for men with prostate cancer who are considering radiation therapy. It's focused on preserving sexual function by protecting nerves and blood vessels during treatment. Participants should be suitable for high-precision radiotherapy and willing to undergo a detailed mapping process before each session.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo MRI or CT-guided SBRT with or without daily plan adaptation for a total of 5 treatments over 18 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of sexual function and urinary symptoms
Long-term follow-up
Assessment of long-term outcomes including sexual function and PSA levels at 24 months and 5 years
What Are the Treatments Tested in This Trial?
Interventions
- Neurovascular Sparing Stereotactic Body Radiation Therapy
Trial Overview
The study tests neurovascular sparing stereotactic body radiation therapy (SBRT) using CT or MRI guidance at UCLA. The goal is to adapt the radiation dose in real-time over five sessions, aiming to minimize damage to critical structures related to erectile function.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or on consecutive days if necessary, for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or on consecutive days if necessary, for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Viewray Inc.
Industry Sponsor
Citations
Neurovascular bundle sparing in hypofractionated ...
Because of the low α / β of prostate cancer [1], SBRT has shown promising outcomes in the treatment of localized prostate cancer [2], [3], [4]. It utilizes high ...
Vascular Optimized Radiotherapy Tuned to Critical ...
Sometimes after radiation therapy, patients may experience problems that affect the urinary and bowel systems, along with sexual function.
3.
papers.ssrn.com
papers.ssrn.com/sol3/Delivery.cfm/23dd680d-34dd-486a-bc2f-f6e295226db9-MECA.pdf?abstractid=4904075&mirid=1Sparing of the Neurovascular Bundles Maintained in the ...
Health-related quality of life after. 234 stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of.
Shorter radiation improves patient experience but not ...
Regarding disease-free survival, 88.6% of patients in the SBRT group were free from disease progression after three years, compared to 92.1% ...
Sexual Structure Sparing for Prostate Cancer Radiotherapy
No significant improvement has been shown in sexual quality of life over time, with erectile dysfunction rates ranging between 40% to 67% in modern RT ...
Stereotactic Body Radiation Therapy: A Radiosurgery ...
External beam radiation therapy (RT) is a safe and effective curative treatment modality for men with localized prostate cancer (PCa). While ...
Sexual Function and Radiation Dose to the Penile Bulb ...
The long-term results and outcome of our SBRT schedule with a 10% dose reduction to the urethra were similar between patients treated every other day and ...
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