NCT07293585 Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment
| NCT ID | NCT07293585 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2035-12-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2025-12-16 with a primary completion date of 2035-12-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18. 2. Histologically confirmed, clinically localized adenocarcinoma of the prostate. 3. 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. 4. 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). 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 6. Ability to undergo magnetic resonance angiography (MRA) of the pelvis. 7. No indication for urgent or emergent radiation. 8. 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: 1. Patients with neuroendocrine or small cell carcinoma of the prostate. 2. 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. 3. Evidence of intraprostatic lesion by biopsy, MRI, or PSMA PET/CT within the middle third, or both lateral thirds of the prostate gland. 4. History of whole-gland cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate. 5. Prior pelvic radiotherapy. 6. History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia. 7. Penile prosthesis or implant present prior to treatment.
Contact & Investigator
Amar Kishan, MD
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07293585 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07293585 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT07293585 currently recruiting?
Yes, NCT07293585 is actively recruiting participants. Contact the research team at cpalodichuk@mednet.ucla.edu for enrollment information.
Where is the NCT07293585 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07293585 clinical trial?
NCT07293585 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Amar Kishan, MD at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 200 participants.
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