Description:
This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify
patients for two different radiotherapy regimens based on the presence/absence of
identifiable intraprostatic lesions.
In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions
(fractions) will be administered.
In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered
followed by an SBRT prostate boost while simultaneously treating the prostate cancer
lesion(s) to a higher dose in 3 fractions.
Title
- Brief Title: MRI Guided SBRT for Localized Prostate Cancer
- Official Title: Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
mpMRI SBRT Prostate
- SECONDARY ID:
15060207
- NCT ID:
NCT03778112
Conditions
Purpose
This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify
patients for two different radiotherapy regimens based on the presence/absence of
identifiable intraprostatic lesions.
In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions
(fractions) will be administered.
In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered
followed by an SBRT prostate boost while simultaneously treating the prostate cancer
lesion(s) to a higher dose in 3 fractions.
Detailed Description
Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional
RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated
RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study
combines the benefits of RT dose escalation while shortening the overall RT treatment course.
In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified
to two separate SBRT regimens depending on whether prostate lesions are present. For patients
without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach
will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive
IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a
SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB)
(21 Gy in 3 fractions) to intraprostatic lesion(s) only.
Patients will be regularly assessed every 3 months for the first 2 years and then every 6
months, indefinitely. Side effects will be monitored using the standardized international
prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at
baseline and subsequent follow-up appointments.
Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk
prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor
control without increasing toxicity, all in a shortened treatment duration.
Trial Arms
Name | Type | Description | Interventions |
---|
Negative mpMRI Prostate Scan | Experimental | SBRT to the whole prostate | |
Positive mpMRI Prostate Scan | Experimental | IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions | |
Eligibility Criteria
Inclusion Criteria:
- Biopsy proven prostate adenocarcinoma within 1 year of randomization
- NCCN Low to High Risk localized prostate cancer
- Zubrod Performance Status 0-1 within 60 days prior to registration
Exclusion Criteria:
- Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
- Regional Lymph Node (N1) involvement
- Distant Metastases (M1) involvement
- History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
- Prior chemotherapy
- Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease;
AIDS)
- Acute bacterial or fungal infection requiring IV antibiotics
- Inability to undergo MRI
- Inability to receive fiducial markers
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of Late Radiation Induced Genitourinary and Gastrointestinal Toxicity |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Rate of Acute Radiation Induced Genitourinary Toxicity |
Time Frame: | 3 months |
Safety Issue: | |
Description: | |
Measure: | Biochemical Recurrence |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | Disease Free-Survival |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Rush University Medical Center |
Trial Keywords
- Prostate Cancer
- Radiotherapy
- SBRT
- Stereotactic Body Radiotherapy
- MRI
Last Updated
January 26, 2021