What this study is
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.
What's being tested
- Stereotactic body radiotherapy (SBRT) Boost
Intervention · RADIATION
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.
Study details
- Official title
- Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer
- Sponsor
- MemorialCare Health System
- Conditions
- Prostate Cancer
- Enrolling
- 150 people
- Starts
- 2012-06
- Est. completion
- 2029-06
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Shelbe Tolentino (Santos) · Contact5629339068stolentino2@memorialcare.org
- Francine Metcalf-Nodwell, CRC · Contact5623137076fmetcalfnodwell@memorialcare.org
Contact for 2 of 3 open sites
- Asif Harsolia, MD · Principal investigator
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
RecruitingSaddleback Memorial Medical Center
Laguna Hills, California, United States
RecruitingLong Beach Memorial Medical Center
Long Beach, California, United States
- Asif Harsolia, MD · Sub-investigator
Recruiting
Study team
Sponsor
MemorialCare Health System
Study ID 065-12
Principal investigator
Asif Harsolia, MD
MemorialCare
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.