Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For P… (NCT06542757) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy
United States91 participantsStarted 2024-12-09
Plain-language summary
The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:
✓. Age \> 18
✓. Karnofsky Performance Status (KPS) \> 80
✓. Prostate size \< 90 cc
✓. Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion
✓. MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
✓. International Prostate Symptom Score \< 18
✓. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
✕. Prior or concurrent androgen deprivation therapy for prostate cancer
✕. MRI findings: suspicious for/probable ECE
✕. MRI findings: \>2 disease foci identifiable
✕. Evidence of metastatic disease on bone scan or MRI/CT
✕. MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.
✕. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI