MRI Guided SBRT for Localized Prostate Cancer

Sponsor

Rush University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03778112

Collaborator

(none)

Enrollment

Location

Arms

153.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: SBRT to whole prostate Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Actual Study Start Date :

May 23, 2016

Actual Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Mar 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Negative mpMRI Prostate Scan SBRT to the whole prostate	Radiation: SBRT to whole prostate Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate
Experimental: Positive mpMRI Prostate Scan IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions	Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions

Arm

Intervention/Treatment

Experimental: Negative mpMRI Prostate Scan

SBRT to the whole prostate

Radiation: SBRT to whole prostate

Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate

Experimental: Positive mpMRI Prostate Scan

IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions

Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions

Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions

Outcome Measures

Primary Outcome Measures

Rate of Late Radiation Induced Genitourinary and Gastrointestinal Toxicity [18 months]

Secondary Outcome Measures

Rate of Acute Radiation Induced Genitourinary Toxicity [3 months]
Biochemical Recurrence [18 months]
Disease Free-Survival [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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