MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer

Phase 2Active Not RecruitingNCT05676463

Thomas Jefferson University6 enrolled

Overview

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.

PRIMARY OBJECTIVE: I. Evaluate late grade 2+ genitourinary (GU) toxicity. SECONDARY OBJECTIVE: I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life. OUTLINE: Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Adenocarcinoma

Interventions

MRI-guided Intensity-Modulated Radiation TherapyPROCEDURE

Undergo MRI-guided IMRT

Antiandrogen TherapyDRUG

Receive SOC ADT

PSMA PET ScanPROCEDURE

Undergo PSMA PET scan

Computed TomographyPROCEDURE

Undergo CT

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Bone ScanPROCEDURE

Undergo bone scan

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Quality-of-Life AssessmentOTHER

Ancillary studies

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: above 18 years * Participants must be histologically proven, adenocarcinoma prostate * Localized to the prostate without positive pelvic lymph node involvement * No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan * High 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/mL * Ability to receive long term hormone therapy * Karnofsky performance score (KPS) \> 70 * No prior history of therapeutic irradiation to pelvis * Patient willing and reliable for follow-up and quality of life (QOL) * English speaking/reading Exclusion Criteria: * Evidence of distant or pelvic metastasis at any time since presentation * Life expectancy \< 2 years * Previous radiation therapy (RT) to prostate or prostatectomy * A 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 RT * Patients with known obstructive symptoms with stricture * Any contraindication to radiotherapy such as inflammatory bowel disease

Outcomes

Primary Outcomes

Rate of late grade 2+ genitourinary (GU) toxicity

Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.

Time frame: At 1 year