Clinical trial NCT03778112: MRI Guided SBRT for Localized Prostate Cancer
Official title: Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radiotherapy
SBRT
Stereotactic Body Radiotherapy
MRI
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
timeFrame: 18 months
Secondary outcomes:
measure: Number of Participants With Acute Radiation Induced Genitourinary Adverse Event
timeFrame: 3 months
measure: Biochemical Recurrence
timeFrame: 18 months
measure: Disease Free-Survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Dian Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: