MRI Guided SBRT for Localized Prostate Cancer

Rush

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: SBRT to whole prostate; Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions

Study type: Interventional

Funder types: Other

Identifiers

NCT03778112

mpMRI SBRT Prostate | 15060207

15060207 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Negative mpMRI Prostate Scan

Experimental group

Description:

SBRT to the whole prostate

Treatment:

Radiation: SBRT to whole prostate

Positive mpMRI Prostate Scan

Experimental group

Description:

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

Treatment:

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