Prostate CancerNCT02016248
SBRT Boost for Unfavorable Prostate Cancer'
A study testing Stereotactic body radiotherapy (SBRT) Boost in people with Prostate Cancer, run by MemorialCare Health System at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic body radiotherapy (SBRT) Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708
Shelbe Tolentino (Santos), 562-933-9068, stolentino2@memorialcare.org
Francine Metcalf-Nodwell, CRC, 5623137076, fmetcalfnodwell@memorialcare.org
- Recruiting
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Shelbe Tolentino (Santos), 5629339068, stolentino2@memorialcare.org
Francine Metcalf-Nodwell, CRC, 5623137076, fmetcalfnodwell@memorialcare.org
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Shelbe Tolentino (Santos), 5629339068, stolentino2@memorialcare.org
Francine Metcalf-Nodwell, CRC, 5623137076, fmetcalfnodwell@memorialcare.org
About this study
Official title: Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer
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.
Read the detailed description
This study is designed to evaluate whether delivering a stereotactic body radiotherapy (SBRT) boost-a short course of five high-dose, precisely targeted radiation treatments-can safely and effectively replace the traditional invasive high dose rate (HDR) brachytherapy boost for men with unfavorable, high-risk, or very high-risk localized prostate cancer. The SBRT boost uses imaging-guided systems and gold fiducial markers to track prostate motion in real time, allowing submillimeter accuracy without placing needles inside the prostate. Treatment planning incorporates CT/MRI fusion, careful mapping of the urethra, and strict dose-volume limits for nearby organs such as the rectum and bladder to ensure the boost achieves HDR-equivalent tumor dosing while minimizing toxicity. All patients also receive standard external beam radiation therapy to the pelvis, and the combined course is designed based on biological dose modeling and prior HDR clinical experience to optimize tumor control while maintaining acceptable side-effect rates.
The protocol also includes structured follow-up and ongoing safety monitoring to track side effects, prostate-specific antigen (PSA) response, and quality-of-life outcomes. Patients are assessed at regular intervals-from two weeks post-treatment through five years-with physical exams, PSA testing, toxicity evaluations, and validated questionnaires measuring urinary and sexual function. Imaging such as prostate-specific membrane antigen (PSMA) PET/CT or bone scans is performed if biochemical failure or symptoms suggest disease progression. The study's primary goals are to determine the rate of significant gastrointestinal and genitourinary side effects and to measure biochemical disease-free survival at five years, while secondary goals include evaluating local and distant tumor control and longer-term survival outcomes. Stopping rules, adverse-event reporting procedures, and quality-assurance requirements are built into the protocol to ensure patient safety and regulatory compliance throughout the study.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic body radiotherapy (SBRT) Boost
- Keywords
- Boost, Prostate Cancer, Stereotactic Body Radiation, SBRT, Radiosurgery, SABR, Stereotactic Ablative Body Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT) BoostRadiation
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 group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy Boost | Experimental | All participants receive the same treatment: standard external-beam radiation therapy (EBRT) plus an SBRT boost. Receives: Radiation: Stereotactic body radiotherapy (SBRT) Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Secondary outcomes (1)
Local Failure Rate
The study looks at whether the cancer comes back in the prostate or spreads elsewhere, how long patients stay cancer-free, and how long they live with or without prostate cancer. It also measures overall survival from any cause and tracks changes in urinary and sexual function using brief questionnaires over time. These outcomes are monitored throughout regular follow-up visits for up to 5 years, with some patients followed as long as 10 years if the investigators choose to continue long-term monitoring.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asif Harsolia, MD, MemorialCare Health System
- Investigators
- Asif Harsolia, MD, Principal investigator, MemorialCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016248
- Sponsor's protocol ID
- 065-12
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2012
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Stereotactic Body Radiotherapy Boost for Unfavorable Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02016248
- Acronym / sponsor ID
- 065-12
- Conditions
- Prostate Cancer
- Keywords
- Boost, Prostate Cancer, Stereotactic Body Radiation, SBRT, Radiosurgery, SABR, Stereotactic Ablative Body Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate whether delivering a stereotactic body radiotherapy (SBRT) boost-a short course of five high-dose, precisely targeted radiation treatments-can safely and effectively replace the traditional invasive high dose rate (HDR) brachytherapy boost for men with unfavorable, high-risk, or very high-risk localized prostate cancer. The SBRT boost uses imaging-guided systems and gold fiducial markers to track prostate motion in real time, allowing submillimeter accuracy without placing needles inside the prostate. Treatment planning incorporates CT/MRI fusion, careful mapping of the urethra, and strict dose-volume limits for nearby organs such as the rectum and bladder to ensure the boost achieves HDR-equivalent tumor dosing while minimizing toxicity. All patients also receive standard external beam radiation therapy to the pelvis, and the combined course is designed based on biological dose modeling and prior HDR clinical experience to optimize tumor control while maintaining acceptable side-effect rates.
The protocol also includes structured follow-up and ongoing safety monitoring to track side effects, prostate-specific antigen (PSA) response, and quality-of-life outcomes. Patients are assessed at regular intervals-from two weeks post-treatment through five years-with physical exams, PSA testing, toxicity evaluations, and validated questionnaires measuring urinary and sexual function. Imaging such as prostate-specific membrane antigen (PSMA) PET/CT or bone scans is performed if biochemical failure or symptoms suggest disease progression. The study's primary goals are to determine the rate of significant gastrointestinal and genitourinary side effects and to measure biochemical disease-free survival at five years, while secondary goals include evaluating local and distant tumor control and longer-term survival outcomes. Stopping rules, adverse-event reporting procedures, and quality-assurance requirements are built into the protocol to ensure patient safety and regulatory compliance throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy Boost | Experimental | Radiation: Stereotactic body radiotherapy (SBRT) BoostAll participants receive the same treatment: standard external-beam radiation therapy (EBRT) plus an SBRT boost. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT) BoostThe 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. | Radiation | Stereotactic Body Radiation Therapy Boost |
Primary outcome
Rate of Grade 3-5 Gastrointestinal (GI) and Genitourinary (GU) Toxicities
Time frame: 5 years
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).
1 secondary outcome
Local Failure Rate
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asif Harsolia, MD principal investigator
MemorialCare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy (SBRT) Boost in people with Prostate Cancer, run by MemorialCare Health System at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelbe Tolentino (Santos) (562-933-9068, stolentino2@memorialcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Grade 3-5 Gastrointestinal (GI) and Genitourinary (GU) Toxicities (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.