MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
- Conditions
- Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Prostate Adenocarcinoma
- Interventions
- Procedure: MRI-guided Intensity-Modulated Radiation TherapyDrug: Antiandrogen TherapyProcedure: PSMA PET ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Bone ScanProcedure: Biospecimen CollectionOther: Quality-of-Life Assessment
- Registration Number
- NCT05676463
- Lead Sponsor
- Thomas Jefferson University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Male
- Target Recruitment
- 88
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (MRI-guided IMRT, ADT) Computed Tomography Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) MRI-guided Intensity-Modulated Radiation Therapy Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) Antiandrogen Therapy Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) Bone Scan Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) PSMA PET Scan Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) Quality-of-Life Assessment Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) Magnetic Resonance Imaging Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial. Treatment (MRI-guided IMRT, ADT) Biospecimen Collection Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
- Primary Outcome Measures
Name Time Method Rate of late grade 2+ genitourinary (GU) toxicity At 1 year 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.
- Secondary Outcome Measures
Name Time Method Quality of life measurement every 6 months beginning at year 2, assessed up to 4 years Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Incidence of late GI toxicity every 6 months beginning at year 2, assessed up to 4 years Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of acute GU and gastrointestinal (GI) toxicity every 6 months beginning at year 2, assessed up to 4 years Will be estimated using a binomial proportion and exact 95% confidence interval.
Prostate cancer specific survival every 6 months beginning at year 2, assessed up to 4 years Will be estimated using the Kaplan-Meier method.
Biochemical failure every 6 months beginning at year 2, assessed up to 4 years Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Overall survival every 6 months beginning at year 2, assessed up to 4 years Will be estimated using the Kaplan-Meier method.
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States