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Recruiting
NCT05676463
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
Conditions: Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
Sex: Male
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 88
Sponsor: Thomas Jefferson University
Location: United States
Summary
This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer.
MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue.
Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.
Eligibility Criteria
Inclusion Criteria:Age: above 18 yearsParticipants must be histologically proven, adenocarcinoma prostateLocalized to the prostate without positive pelvic lymph node involvementNo distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scanHigh risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8-10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mLAbility to receive long term hormone therapyKarnofsky performance score (KPS) > 70No prior history of therapeutic irradiation to pelvisPatient willing and reliable for follow-up and quality of life (QOL)English speaking/readingExclusion Criteria:Evidence of distant or pelvic metastasis at any time since presentationLife expectancy < 2 yearsPrevious radiation therapy (RT) to prostate or prostatectomyA previous trans-urethral resection of the prostate (TURP)Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RTPatients with known obstructive symptoms with strictureAny contraindication to radiotherapy such as inflammatory bowel disease
Source: ClinicalTrials.gov (NCT05676463). StuddyBuddy aggregates publicly available trial information.