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MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist re-optimize the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size/shape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18

• 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

⁃ 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 are amenable)

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• 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

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Carol W. Felix
cfelix@mednet.ucla.edu
310-825-9771
Backup
Christy Palodichuck
cpalodichuk@mednet.ucla.edu
+1 310-794-2971
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 186
Treatments
Active_comparator: Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD 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.
Experimental: Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD 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.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI), Viewray Inc.

This content was sourced from clinicaltrials.gov