SBRT Boost for Unfavorable Prostate Cancer'
Part of paid clinical trials in Fountain Valley, California.
- Sponsor
- MemorialCare Health System
- Study ID
- NCT02016248
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Stereotactic body radiotherapy (SBRT) Boost — RADIATIONThe 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
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.
Key Dates
- Start date
- Jun 30, 2012
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Stereotactic Body Radiation Therapy BoostAll participants receive the same treatment: standard external-beam radiation therapy (EBRT) plus an SBRT boost.
Primary Outcome Measure
Rate of Grade 3-5 Gastrointestinal (GI) and Genitourinary (GU) Toxicities [ Time Frame: 5 years ]
Central Contacts
- Shelbe Tolentino (Santos)562-933-9068
- Francine Metcalf-Nodwell562-313-7076
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | Asif Harsolia, MD (PRINCIPAL_INVESTIGATOR) |
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | Asif Harsolia, MD (PRINCIPAL_INVESTIGATOR) |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | Asif Harsolia, MD (SUB_INVESTIGATOR) |
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