NCT07276438 · Jonsson Comprehensive Cancer Center
Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Computed Tomography
Undergo CT
RADIATION
CT-guided Stereotactic Body Radiation Therapy
Undergo CT-guided SBRT
OTHER
Inter-fraction Adaptation of Treatment Plan
Undergo daily plan adaptation
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
RADIATION
MRI-guided Stereotactic Body Radiation Therapy
Undergo MRI-guided SBRT
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
Time frame: From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT
A clinically relevant decrement in the EPIC-26 urinary irritative/obstructive domain is defined as greater than 14 points. Will compare the proportion of patients with a clinically relevant in genitourinary EPIC-26 urinary irritative/obstructive subdomain within 90 days of study therapy via a simple binomial test for differences in proportions. A more granular analysis will be based on the cumulative incidence method will be used to summarize risk of clinically relevant decline and Fine-Gray test will be used to compare cumulative incidences between the two arms. The analysis population includes all randomized subjects based on intent-to-treat principle. Point estimates as well as the associated 95% confidence intervals will be reported. Will also be evaluated using a multivariable analysis adjusted for variables including a simultaneous integrated boost, use of nodal radiotherapy, and use of hydrogel spacers.
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
- 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
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
- Prior 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
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data
Where
- Los Angeles, California
Collaborators
Viewray Inc., National Cancer Institute (NCI)
Related conditions & keywords
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.
Will I be compensated?
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?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
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 Feb 5, 2026 · Source of record for eligibility and locations