Adenocarcinoma of the ProstateNCT02296229
Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer
A study testing stereotactic body radiation therapy, quality-of-life assessment and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage III Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Stage III Prostate Cancer
- What is being tested?
- stereotactic body radiation therapy, quality-of-life assessment and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2014to 27 Jan 2027
- 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 confirmed primary non-metastatic adenocarcinoma of the prostate
- Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:
- Pre-biopsy prostate-specific antigen (PSA) >= 20
- Biopsy Gleason score 8-10
- Clinical stage T3
- No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)
Show all 12Show fewer
- No distant metastases, based upon:
- CT scan or MRI of the pelvis within 120 days prior to registration
- Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
- Karnofsky performance status (KPS) >= 70
- Ability to understand, and willingness to sign, the written informed consent
- Patient will have opted for SBRT among definitive treatment choices
Who cannot join
- Patients with any evidence of distant metastases
- Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
- Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- Prior pelvic radiotherapy
- History of Crohn’s disease or Ulcerative colitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.
II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.
III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.
OUTLINE:
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.
- Being tested
- stereotactic body radiation therapy, quality-of-life assessment, laboratory biomarker analysis, androgen deprivation therapy
- 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 radiation therapyRadiation
Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo SBRT
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
androgen deprivation therapyDrug
Also called androgen suppression therapy
up to 9 months at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT) | Experimental | Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. Receives: Radiation: stereotactic body radiation therapy; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Drug: androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical progression free survival
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Measured: At 3 years
Biochemical progression free survival
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Measured: At 5 years
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: At 4 months
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
Measured: Up to 5 years
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire
Measured: Baseline to up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start27 Jan 2014
- Primary completion27 Jan 2026
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amar Kishan, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296229
- Sponsor's protocol ID
- 13-001427
- Other IDs
- NCI-2014-02183, JCCCID410, 13-001427
- Status last verified
- Feb 2025
- First submitted
- 13 Nov 2014
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer
- ClinicalTrials.gov ID
- NCT02296229
- Acronym / sponsor ID
- 13-001427
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Jan 2014 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 20 Nov 2014 (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.
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.
II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.
III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.
OUTLINE:
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT) | Experimental | Radiation: stereotactic body radiation therapy, Other: quality-of-life assessment, Other: laboratory biomarker analysis, Drug: androgen deprivation therapyPatients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:
- No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)
- No distant metastases, based upon:
- Karnofsky performance status (KPS) >= 70
Key exclusion criteria (5 listed)
- Patients with any evidence of distant metastases
- Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
- Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- Prior pelvic radiotherapy
- History of Crohn’s disease or Ulcerative colitis
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 radiation therapyAlso: SBRT, stereotactic radiation therapy, stereotactic radiotherapyUndergo SBRT | Radiation | Treatment (SBRT) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Treatment (SBRT) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (SBRT) |
| androgen deprivation therapyAlso: androgen suppression therapyup to 9 months at the discretion of the treating physician | Drug | Treatment (SBRT) |
Primary outcome
Biochemical progression free survival
Time frame: At 3 years
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Biochemical progression free survival
Time frame: At 5 years
Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: At 4 months
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
Time frame: Up to 5 years
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire
Time frame: Baseline to up to 5 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 25 Feb 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. This study is not recruiting at the moment.
Amar Kishan principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body radiation therapy, quality-of-life assessment and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Stage III Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site 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 12 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical progression free survival (time frame: At 3 years). The study lists 5 primary outcomes in all. 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 25 Feb 2026.