Image-Guided SBRT for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of using Stereotactic Body Radiation Therapy for prostate cancer that remains confined to the prostate. It compares two approaches: one adjusts the treatment plan daily based on the patient's current anatomy, and the other does not. The goal is to determine if daily adjustments can reduce side effects while effectively treating the cancer. This trial is for patients diagnosed with prostate cancer contained within the prostate who have not undergone certain prior treatments, such as pelvic radiotherapy. As an unphased trial, it offers patients the chance to contribute to innovative research that may enhance future prostate cancer treatments.
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 team or your doctor.
What prior data suggests that image-guided SBRT with online adaptation is safe for treating localized prostate cancer?
Research shows that adaptive stereotactic body radiation therapy (SBRT) for prostate cancer is generally safe. Studies indicate it is well-tolerated and carries a low risk of side effects. For example, patients report few treatment-related side effects, with most not experiencing severe negative effects. Additionally, evidence suggests that adaptive SBRT is both safe and effective while shortening overall treatment time. This method allows doctors to adjust radiation plans based on daily changes in the body, potentially reducing side effects. Overall, adaptive SBRT appears to be a promising and safe option for treating localized prostate cancer.12345
Why are researchers excited about this trial?
Researchers are excited about image-guided Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a more precise approach compared to traditional radiation treatments. This trial explores two methods: adaptive SBRT, which adjusts the treatment plan daily based on MRI or CT scans, potentially improving accuracy and minimizing damage to healthy tissue, and non-adaptive SBRT, which follows a set plan. Both methods aim to deliver high doses of radiation over just five sessions, reducing the treatment period to 18 days. This approach could lead to fewer side effects and a more convenient treatment experience for patients.
What evidence suggests that image-guided SBRT with online adaptation is effective for treating localized prostate cancer?
Research has shown that stereotactic body radiation therapy (SBRT) effectively treats prostate cancer that hasn't spread. Studies indicate that patients receiving SBRT have a high chance of remaining cancer-free for five years: 95% for low-risk, 84% for intermediate-risk, and 81% for high-risk prostate cancer. In this trial, participants will receive either adaptive SBRT or non-adaptive SBRT. Adaptive SBRT, which adjusts treatment based on daily changes in the body, may reduce side effects by focusing more precisely on the tumor and protecting healthy tissue. Reports from patients suggest that adaptive SBRT effectively manages side effects. Overall, these findings suggest that SBRT, especially when adapted, is a promising treatment option for localized prostate cancer.12346
Who Is on the Research Team?
Amar Kishan
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Men with localized prostate adenocarcinoma, which hasn't spread to other body parts, can join this trial. Participants should be suitable for stereotactic body radiation therapy (SBRT) and willing to undergo various imaging procedures like CT or MRI scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients 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
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Body Radiation Therapy
Trial Overview
The MANTICORE Trial is testing image-guidance and online adaptation in SBRT for treating localized prostate cancer. It compares standard SBRT planning with a new approach that adjusts the plan daily based on changes in bladder and prostate size/shape.
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 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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Viewray Inc.
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Stereotactic Body Radiation Therapy for Prostate Cancer is ...
Of the 267 patients, 124 (46%) had low-risk, 73 (27%) had favorable intermediate-risk, and 70 (26%) had unfavorable intermediate-risk disease according to the ...
NCT07219303 | Adaptive Radiation Therapy for Men With ...
This is a phase 1 dose finding study investigating escalated doses of adaptive prostate SBRT for patients with intermediate and favorable high ...
Five-year outcomes of stereotactic body radiation therapy ...
Majority of studies using SBRT indicated that the 5-year bPFS for patients with low-, intermediate-, and high-risk PCa was 95%, 84% and 81%, respectively (King ...
Acute and Late Patient-Reported Toxicity Outcomes
Our study is one of the largest patient-reported outcome studies after stereotactic MR-guided adaptive radiation therapy for localized prostate ...
Stereotactic body radiation therapy for prostate cancer after ...
All the five patients (17.9 %) with a previous history of TURP treated with SBRT presented a grade 3 GU toxicity compared to only one single patient in the VMAT ...
Comparison of Adaptive Magnetic Resonance Guided and ...
Adaptive stereotactic body radiation therapy (SBRT) for prostate cancer has shown to be safe and effective, while shortening overall treatment time.
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