Trial Search Results

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

The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

NRG Oncology

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Radiation: Intensity-Modulated Radiation Therapy (IMRT)
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)

Phase:

Phase 3

Eligibility


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; (AJCC, version 7) or 3) Group Grade 1 or 2

         - 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).

      - Percent of submitted positive core biopsies must be < 50% of all sextants
      (Sextant refers to the bilateral base, mid and apex of the gland and the left and
      right, resulting in six sections or sextants. Biopsies may take 2 from each
      sextant. If more than 12 are sampled, some may be from a targeted region possibly
      with multiple cores to ensure adequate tissue.)

         - NOTE: all cores from a targeted lesion will be counted as an N of 1 core for
         calculating percent positive cores in total

      - The prostate volume must be < 60 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
   registration

   - MRI of pelvis (compliant with PIRADSv2 guidelines) within 90 days prior to
   registration

   - Bone scan or sodium fluoride positron emission tomography (PET) scan within 90 days
   prior to registration

   - Charlson modified co-morbidity score =< 3 for patients under 60 and =< 4 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 3 years

   - 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; [applicable
   only to studies that incorporate systemic therapy]

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kim Nguyen
650-497-8966
Recruiting