NCT07276438 Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial
| NCT ID | NCT07276438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Localized Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2031-12-31 |
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.
This trial targets 186 participants in total. It began in 2025-12-01 with a primary completion date of 2031-12-31.
⚠ 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
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 Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Amar W. Kishan, MD
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07276438 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Localized Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07276438 currently recruiting?
Yes, NCT07276438 is actively recruiting participants. Contact the research team at cfelix@mednet.ucla.edu for enrollment information.
Where is the NCT07276438 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07276438 clinical trial?
NCT07276438 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Amar W. Kishan, MD at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 186 participants.