Recruiting

CyberKnife

Sponsor:

MemorialCare Health System

Code:

NCT02016248

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic body radiotherapy (SBRT) Boost

Study Details

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

Study ID

NCT02016248

Start date

Jun, 2012

Status verified date

Jan, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 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

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic Body Radiation Therapy Boost

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

Interventions

Stereotactic body radiotherapy (SBRT) Boost

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.

Primary outcome measure

  • Rate of Grade 3-5 Gastrointestinal (GI) and Genitourinary (GU) Toxicities [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Shelbe Tolentino (Santos)

562-933-9068stolentino2@memorialcare.org

Francine Metcalf-Nodwell

562-313-7076fmetcalfnodwell@memorialcare.org

Locations

Orange Coast Memorial Medical Center

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Shelbe Tolentino (Santos)

562-933-9068stolentino2@memorialcare.org

Francine Metcalf-Nodwell, CRC

5623137076fmetcalfnodwell@memorialcare.org

Principal Investigator:

Asif Harsolia, MD

Saddleback Memorial Medical Center

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Shelbe Tolentino (Santos)

5629339068stolentino2@memorialcare.org

Francine Metcalf-Nodwell, CRC

5623137076fmetcalfnodwell@memorialcare.org

Principal Investigator:

Asif Harsolia, MD

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Shelbe Tolentino (Santos)

5629339068stolentino2@memorialcare.org

Francine Metcalf-Nodwell, CRC

5623137076fmetcalfnodwell@memorialcare.org

More Information

Sponsor

MemorialCare Health System

Last update posted

Mar 30, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MemorialCare Health System on 2026-03-30.