RecruitingNot ApplicableNCT02016248

SBRT Boost for Unfavorable Prostate Cancer'

Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer


Sponsor

MemorialCare Health System

Enrollment

150 participants

Start Date

Jun 1, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out whether giving a short course of focused radiation called an SBRT "boost" is a safe and effective way to treat prostate cancer. This boost delivers a high dose of radiation to the prostate in a non-invasive way, similar to what is done with high dose rate (HDR) brachytherapy but without using needles. The study looks at how well this treatment controls the cancer, what side effects it may cause, and how it affects patients' quality of life over time.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria18

  • Inclusion
  • Histologically proven prostate adenocarcinoma
  • Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient.
  • Clinical Stage I-IV, MX-M0 (AJCC VERSION 9)
  • M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy.
  • Prostate volume: ≤ 100 cc (recommended not required)
  • Determined using: volume = π/6 x length x height x width
  • Measurement from CT, MRI or ultrasound ≤ 90 days prior to registration.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No prior prostatectomy or cryotherapy of the prostate
  • No prior radiotherapy to the prostate or lower pelvis
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • Completion of patient questionnaires in section 3.7.
  • Consent signed
  • Exclusion
  • No prior prostatectomy or cryotherapy of the prostate
  • No prior radiotherapy to the prostate or lower pelvis
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.

Interventions

RADIATIONStereotactic Body Radiotherapy

The intervention in this study is the SBRT boost, which is a short course of five high-dose stereotactic body radiotherapy treatments (5.5 Gy × 5 fractions, total 27.5 Gy) delivered with image-guided precision to the prostate. This SBRT boost is given in addition to standard external-beam radiation therapy (EBRT), which delivers 50.4 Gy to the pelvis, prostate, and proximal seminal vesicles.


Locations(3)

Orange Coast Memorial Medical Center

Fountain Valley, California, United States

Saddleback Memorial Medical Center

Laguna Hills, California, United States

Long Beach Memorial Medical Center

Long Beach, California, United States

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NCT02016248


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