Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT07293585

Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-12-19

200

Participants Needed

1

Research Sites

574 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

V

Viewray Inc.

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed, clinically localized adenocarcinoma of the prostate
  • Staging workup according to National Comprehensive Cancer Network guidelines based on risk grouping
  • Advanced imaging such as PSMA PET/CT or fluciclovine PET/CT allowed instead of bone scan if done first
  • No metastatic disease above the renal artery bifurcation; nodal disease below is allowed
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Ability to undergo magnetic resonance angiography of the pelvis
  • No urgent or emergency need for radiation therapy
  • Ability to provide informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Neuroendocrine or small cell carcinoma of the prostate
  • Evidence of distant metastases except nodal disease below renal arteries
  • Intraprostatic lesion in the middle third or both lateral thirds of prostate
  • History of whole-gland cryosurgery, high-intensity focused ultrasound, brachytherapy, or other ablative prostate treatments
  • Prior pelvic radiotherapy
  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
  • Presence of penile prosthesis or implant before treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California at Los Angeles

Los Angeles, California, United States, 90045

Actively Recruiting

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Research Team

C

Christy Palodichuk

CONTACT

C

Care Felix

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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