SBRT Boost for Unfavorable Prostate Cancer'

NCT02016248 | Recruiting

• 1 other identifier: 065-12
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer

Keywords

Boost; Prostate Cancer; Stereotactic Body Radiation; SBRT; Radiosurgery; SABR; Stereotactic Ablative Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of Grade 3-5 Gastrointestinal (GI) and Genitourinary (GU) Toxicities

  This outcome measures how many participants experience severe (grade 3-5) side effects involving the gastrointestinal or genitourinary systems after receiving the SBRT boost. Toxicities are evaluated using the NCI Common Terminology Criteria for Adverse Events (CTCAE).

  5 years

Secondary Outcomes (1)

• Local Failure Rate

  10 years

Study Arms (1)

Stereotactic Body Radiation Therapy Boost

EXPERIMENTAL

All participants receive the same treatment: standard external-beam radiation therapy (EBRT) plus an SBRT boost.

Radiation: Stereotactic body radiotherapy (SBRT) Boost

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.

Stereotactic Body Radiation Therapy Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (3)

Orange Coast Memorial Medical Center

Fountain Valley, California, 92708, United States

RECRUITING

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

RECRUITING

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Asif Harsolia, MD

  MemorialCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelbe Tolentino (Santos)

CONTACT

562-933-9068; stolentino2@memorialcare.org

Francine Metcalf-Nodwell

CONTACT

562-313-7076; fmetcalfnodwell@memorialcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 19, 2013
• Study Start: June 1, 2012
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-01

Locations

US (3)