Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
Overview
- Phase
- Phase 2
- Intervention
- MRI-guided Intensity-Modulated Radiation Therapy
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Thomas Jefferson University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Rate of late grade 2+ genitourinary (GU) toxicity
- Status
- Terminated
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: MRI-guided Intensity-Modulated Radiation Therapy
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: Antiandrogen Therapy
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: PSMA PET Scan
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: Computed Tomography
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: Magnetic Resonance Imaging
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: Bone Scan
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: Biospecimen Collection
Treatment (MRI-guided IMRT, ADT)
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.
Intervention: Quality-of-Life Assessment
Outcomes
Primary Outcomes
Rate of late grade 2+ genitourinary (GU) toxicity
Time Frame: 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 Outcomes
- Quality of life measurement(every 6 months beginning at year 2, assessed up to 4 years)
- Incidence of late GI toxicity(every 6 months beginning at year 2, assessed up to 4 years)
- Incidence of acute GU and gastrointestinal (GI) toxicity(every 6 months beginning at year 2, assessed up to 4 years)
- Prostate cancer specific survival(every 6 months beginning at year 2, assessed up to 4 years)
- Biochemical failure(every 6 months beginning at year 2, assessed up to 4 years)
- Overall survival(every 6 months beginning at year 2, assessed up to 4 years)
- Prostate cancer specific survival(At treatment completion, up to 10 days)
- Prostate cancer specific survival(every 3 months after treatment until 1 year)
- Incidence of acute GU and gastrointestinal (GI) toxicity(At baseline)
- Incidence of acute GU and gastrointestinal (GI) toxicity(At treatment completion, up to 10 days)
- Incidence of acute GU and gastrointestinal (GI) toxicity(every 3 months after treatment until 1 year)
- Incidence of late GI toxicity(At baseline)
- Incidence of late GI toxicity(At treatment completion, up to 10 days)
- Incidence of late GI toxicity(every 3 months after treatment until 1 year)
- Overall survival(At baseline)
- Overall survival(At treatment completion, up to 10 days)
- Overall survival(every 3 months after treatment until 1 year)
- Prostate cancer specific survival(At baseline)
- Biochemical failure(At baseline)
- Biochemical failure(At treatment completion, up to 10 days)
- Biochemical failure(every 3 months after treatment until 1 year)
- Quality of life measurement(At baseline)
- Quality of life measurement(At treatment completion, up to 10 days)
- Quality of life measurement(every 3 months after treatment until 1 year)