MRI Guided SBRT for Localized Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | May 23, 2016 |
| End Date: | May 2021 |
| Contact: | Robert Stines, RN |
| Email: | robert_stines@rush.edu |
| Phone: | 312-563-0789 |
Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
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.
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.
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.
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.
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
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Dian Wang, MD, PhD
Phone: 312-942-5751
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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