NCT07293585 · Jonsson Comprehensive Cancer Center
Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment
(VORTEX)
What this study is about
With people living longer after being treated for prostate cancer, quality of life has become a concern when considering the treatment plan. Sometimes after radiation therapy, patients may experience problems that affect the urinary and bowel systems, along with sexual function. Stereotactic body radiotherapy (SBRT) is a type of radiation technique that delivers five high doses of radiation.
View original scientific description
With people living longer after being treated for prostate cancer, quality of life has become a concern when considering the treatment plan. Sometimes after radiation therapy, patients may experience problems that affect the urinary and bowel systems, along with sexual function. Stereotactic body radiotherapy (SBRT) is a type of radiation technique that delivers five high doses of radiation. At University of California at Los Angeles (UCLA), we have the option to administer SBRT in both our CT-guided and MRI-guided radiation machines. This trial aims to determine the most effective method for protecting the nerves and blood vessels essential for erectile function, utilizing a technique known as neurovascular sparing. This technique uses images (i.e., MRI) to map the neurovascular bundles of nerves and blood vessels, which are crucial for erectile function. "Adapting" the radiotherapy treatment for each of these five treatment sessions could enable a more precise delivery of your radiation treatment that is customized based on your internal anatomy immediately before the treatment starts. This is also a standard and low-risk intervention used in many different types of cancer. However, it is a very labor-intensive and time-consuming procedure that requires a team of experts to work together before each of your radiotherapy sessions. We are unsure if the increased complexity associated with this adaptive treatment reduces side effects.
Interventions
RADIATION
Neurovascular sparing stereotactic body radiation therapy
Use of adaptive radiotherapy
Primary outcome measures
Expanded Prostate Cancer Index Composite (EPIC-26) sexual function Questionnaire
Time frame: 24 months
The primary endpoint is clinically relevant (≥24 point) decline in EPIC-26 sexual function domain scores at 24 months following treatment in patients randomized to NV-sparing SBRT relative to patients randomized to conventional SBRT without explicit NV-sparing.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed, clinically localized adenocarcinoma of the prostate.
- Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping. a. Advanced imaging studies (i.e. prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first.
- No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries is allowable).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Ability to undergo magnetic resonance angiography (MRA) of the pelvis.
- No indication for urgent or emergent radiation.
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
Exclusion criteria
- Patients with neuroendocrine or small cell carcinoma of the prostate.
- Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator.
- Evidence of intraprostatic lesion by biopsy, MRI, or PSMA PET/CT within the middle third, or both lateral thirds of the prostate gland.
- History of whole-gland cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate.
- Prior pelvic radiotherapy.
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.
- Penile prosthesis or implant present prior to treatment.
Where
- Los Angeles, California
Collaborators
Viewray Inc.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2025 · Source of record for eligibility and locations