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

NCT No.: NCT03367702

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

Official Title

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

Purpose

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.

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

• Previously untreated (no local therapy such as surgery, radiation cryotherapy, high-intensity focused ultrasound [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 be 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 patient 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

• Age >= 18

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

• Bone scan as clinically indicated 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 as these are the only languages EPIC-26 has been validated in

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

• 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 melanoma

• 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 is 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; this
  exclusion criterion is necessary because the treatments involved in this protocol may be
  significantly immunosuppressive
  • 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

Keywords and/or Specific Medical Conditions

  • Carcinoma
  • Neoplasms by Histologic Type Adenocarcinoma
  • Neoplasms, Glandular and Epithelial
  • Oncology (Adult)
  • Neoplasms

Sponsors

  • NRG Oncology

KP Clinical Facility

Clinical Area

  • Oncology (Adult)

Principal Investigator

Samantha M Seaward  

Contact Information

 - CTP Digital Solutions
- CTP-DigitalSolutions@kp.org
- All Kaiser Permanente Northern California Medical Centers

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