Image-guided adaptive stereotactic body radiation therapy for localized prostate cancer
MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)
This trial tests whether daily, real-time adaptive image-guided SBRT causes fewer urinary and other side effects than standard non-adaptive SBRT for men with localized prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07276438 on ClinicalTrials.gov |
What this trial studies
Men with localized prostate adenocarcinoma are randomized to receive either conventional MRI/CT-guided SBRT without daily plan changes or daily, real-time adaptive SBRT that adjusts the plan based on same-day imaging. The primary outcome is acute patient-reported genitourinary toxicity, with secondary outcomes including other acute toxicities, long-term quality of life, physician-scored GU and GI toxicity, and 5-year biochemical recurrence-free survival. The trial also collects biospecimens to correlate reported and observed toxicities with a commercial genetic biomarker (PROSTOX). Treatments are delivered over five fractions with imaging before each session for the adaptive arm.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed, clinically localized prostate adenocarcinoma, ECOG performance status 0–2, no metastatic disease above the renal artery bifurcation, and who are eligible for SBRT.
Not a fit: Patients with metastatic disease, non-adenocarcinoma histologies (for example small-cell/neuroendocrine), inability to undergo required imaging, or urgent need for radiation may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, daily adaptive SBRT could reduce acute urinary side effects and improve quality of life while maintaining cancer control.
How similar studies have performed: Image-guided SBRT is an established treatment and early, non-randomized studies of adaptive radiotherapy have shown promising toxicity reductions, but randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Amar W. Kishan, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Carol W. Felix
- Email: cfelix@mednet.ucla.edu
- Phone: 310-825-9771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.