Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

Not Recruiting

Trial ID: NCT03367702


This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Official Title

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

Stanford Investigator(s)

Hilary Bagshaw
Hilary Bagshaw

Clinical Associate Professor, Radiation Oncology - Radiation Therapy

Mark Buyyounouski, MD, MS, FASTRO
Mark Buyyounouski, MD, MS, FASTRO

Professor of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   - Previously untreated (no local therapy such as surgery, radiation cryotherapy, HIFU,
   etc.) localized adenocarcinoma of the prostate with the following clinical findings:

      - Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side
      of the gland); (American Joint Committee on Cancer [AJCC], version 7) or cT1a-c
      or 2a or 2b,

      - Stages T1a-T1b are eligible if patient underwent transurethral prostatic
      resection (TURP),

      - The patient must meet one of the following 3 criteria: 1) Gleason score must be
      Gleason 7(3+4) with a PSA < 20 ng/mL, or 2) Gleason 6(3+3) with a PSA > 10 ng/mL
      and < 20 ng/mL which is considered intermediate risk and eligible for the study.
      (AJCC, version 7) or 3) Group Grade 1 with a PSA > 10 ng/mL and < 20 ng/mL or 2
      with a PSA < 20 ng/mL.

         - If patient is receiving a 5-alpha reductase inhibitor at the time of
         enrollment the baseline PSA value may be double the initial value and the
         medication should be discontinued but a washout period is not required to
         eligible, a PSA drawn while still on the medicine must be:

            - < 10 ng/mL if Gleason 7(3+4) (Note: This patient would be on
            stratification level 1 if PSA < 5 ng/mL and stratification level 2 if
            less than 10 ng/mL).

            - > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (Note: This
            patients would be on stratification level 3).

      - The prostate volume must be < 70 cc as reported at time of biopsy or by separate
      measure with ultrasound or other imaging modalities including magnetic resonance
      imaging (MRI) or computed tomography (CT) scan

      - Patients in active surveillance who elect to be treated are eligible if they meet
      protocol requirements

   - History and physical including a digital rectal exam 60 days prior to registration

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 60 days prior to

   - MRI of the prostate and pelvis (per institutional SOC - should be compliant with
   PIRADSv2.1 guidelines) within 1 year prior to registration

   - Bone scan or sodium fluoride positron emission tomography (PET) scan within 120 days
   prior to registration

   - Charlson modified co-morbidity score =< 4 for patients under 60 and =< 5 for patients
   60 and over 21 days prior to registration

   - International prostate symptom score (IPSS) of < 15 21 days prior to registration

   - The patient must provide study-specific informed consent prior to study entry

   - Willingness and ability to complete the Expanded Prostate Cancer Index Composite
   (EPIC-26) questionnaire

   - Completion of all items of the EPIC-26 which will be data entered at registration 60
   days prior to registration

   - Only English, Spanish, and French-speaking patients are eligible to participate

Exclusion Criteria:

   - Definitive clinical or radiologic evidence of metastatic disease; no nodal involvement
   or evidence of metastatic disease allowed as defined by screening of the pelvis and a
   bone scan or sodium fluoride PET scan

   - Definitive T3 disease on MRI

   - Prior or current invasive malignancy with current evidence of active disease within
   the past 2 years

      - Exceptions: Non-melanomatous skin cancer, carcinoma in situ of the male breast,
      penis, oral cavity, or stage Ta of the bladder, or stage I completely resected

   - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
   different cancer is allowable; must be off treatment for at least 3 years

   - Prior radiotherapy to the region of the study cancer that would result in overlap of
   radiation therapy fields

   - The use of hormonal therapy is not allowed; if the patient in on a 5-alpha reductase
   inhibitor, then they should be stopped prior to treatment once enrolled onto the
   study; no washout period is required for this study to participate

   - Severe, active co-morbidity defined as follows:

      - Human immunodeficiency virus (HIV) positive with CD4 count < 200
      cells/microliter; Note that patients who are HIV positive are eligible, provided
      they are under treatment with highly active antiretroviral therapy (HAART) and
      have a CD4 count >= 200 cells/microliter within 30 days prior to registration;
      Note also that HIV testing is not required for eligibility for this protocol

      - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
      note, however, that laboratory tests for liver function and coagulation
      parameters are not required for entry into this protocol; (patients on Coumadin
      or other blood thinning agents are eligible for this study)

   - Contraindication to MRI

      - Cardiac pacemaker or defibrillator

      - Surgically implanted electrical devices such as spinal stimulation devices or
      intracranial stimulation devices, cochlear implants, the presence of metallic
      foreign bodies in the orbits, and incompatible old mechanical heart valves and
      aneurysm clips


radiation: Intensity-Modulated Radiation Therapy (IMRT)

radiation: Stereotactic Body Radiation Therapy (SBRT)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kim Nguyen

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