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 — 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

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 Boost
    All 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

Locations (3)

FacilityCityStateZIPSite coordinators
Orange Coast Memorial Medical CenterFountain ValleyCalifornia92708
Shelbe Tolentino (Santos)
562-933-9068
Francine Metcalf-Nodwell, CRC
5623137076
Asif Harsolia, MD (PRINCIPAL_INVESTIGATOR)
Saddleback Memorial Medical CenterLaguna HillsCalifornia92653
Shelbe Tolentino (Santos)
5629339068
Francine Metcalf-Nodwell, CRC
5623137076
Asif Harsolia, MD (PRINCIPAL_INVESTIGATOR)
Long Beach Memorial Medical CenterLong BeachCalifornia90806
Shelbe Tolentino (Santos)
5629339068
Francine Metcalf-Nodwell, CRC
5623137076
Asif Harsolia, MD (SUB_INVESTIGATOR)

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