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NCT Number: NCT03778112

MRI Guided 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBRT to whole prostate

Radiation

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

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

Radiation

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

Primary outcomes

  1. Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity

    Time frame: 18 months

    Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.

Secondary outcomes

  1. Number of Participants With Acute Radiation Induced Genitourinary Adverse Event

    Time frame: 3 months

    Adverse acute events are evaluated by the CTEP Active Version of the NCI CTCAE. The treatment-related attribution includes definitely, probably or possibly related to treatment. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of RT. For each cohort, we will evaluate the acute radiation therapy-related adverse events. Specifically, we are interested in the percentage of acute GI and GU Grade 3+ adverse events that occur in each arm, which is considered to be similar to the high RT dose arm of RTOG 0126 in terms of RT dose. For this arm, a reported 1% of patients experienced Grade 3+ GI/GU acute toxicity, with no patient experiencing Grade 4 or 5 toxicities. If either hypofractionated arm has an acceptable percentage, then that arm will be deemed to have an acceptable adverse event profile. We will report the percentage for each arm as well as the one-sided 97.5% confidence interval.

  2. Biochemical Recurrence

    Time frame: 18 months

    Biochemical (PSA) recurrence is defined according to the proposed new Radiation Therapy Oncology Group/American Society for Therapeutic Radiology and Oncology (RTOG-ASTRO) criteria also known as the RTOG Phoenix definition: an increase of the PSA level at least 2 ng/mL greater than the minimum level reached after therapy (lowest PSA+ 2 criterion). PSA failure at 1, 2, and 5 years will be estimated for each cohort by the cumulative incidence method.

  3. Disease Free-Survival

    Time frame: 18 months

    The disease-free survival duration will be measured from the date of registration to the date of documentation of disease progression or until the date of death from any cause. DFS at 1, 2, and 5 years will be estimated for each c o h o r t by the Kaplan-Meier method. Also, 95% confidence intervals will be reported.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2029
First posted
Dec 19, 2018
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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