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New treatment option for Prostate Cancer
Official title SBRT Boost for Unfavorable Prostate Cancer'
ClinicalTrials.gov ID: NCT02016248
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Clinical Stage I-IV, MX-M0 (AJCC VERSION 9)
- M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy.
See the full eligibility criteria
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fountain Valley, California, United States
- Laguna Hills, California, United States
- Long Beach, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fountain Valley, California, United States; Laguna Hills, California, United States; Long Beach, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.