Prostate CancerNCT04552509
TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer
A study testing Stereotactic Body Radiotherapy in people with Prostate Cancer, run by Linda Chan, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of TrueBeam stereotactic body radiosurgery in patients with prostate cancer. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 1 Dec 2026
- 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 Any age
- Men only
- No healthy volunteers
- Child, 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 6th Edition)
- M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients.
- Prostate volume: ≤ 100 cc (recommended not required)
- Determined using: volume = π/6 x length x height x width
Show all 10Show fewer
- Measurement from CT or ultrasound ≤90 days prior to registration.
- ECOG performance status 0-1
- Completion of patient questionnaires in section 4.7.
- Consent signed
Who cannot join
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
United States1 site
MemorialCare Saddleback Medical Center
Laguna Hills, California, 92653
About this study
Official title: Prospective Evaluation of TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified MonoTherapy Versus RADIOSURGERY Boost
The purpose of this study is to determine the effects of TrueBeam stereotactic body radiosurgery in patients with prostate cancer. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time. Radiosurgery is a non-invasive treatment technique used to treat tumors. Despite the word "surgery" in the name, the technology does not remove the tumor with a surgical knife. Instead, a focused, high-intensity beam of radiation targets the tumor, while minimizing dose to surrounding normal healthy tissue.
Read the detailed description
1.0 BACKGROUND 1.1 Prostatic adenocarcinoma is one of the most common forms of malignancy in men. Every year over 200000 patients are diagnosed with prostate cancer in the United States. Treatment options for these patients include active surveillance, radical prostectomy, external beam radiation therapy, permanent source interstitial brachytherapy and high dose rate (HDR) brachytherapy.
1.2 Each of these treatment options vary in regards to the logistics, anticipated outcomes, and potential side effects of therapy.
1.3 High-dose rate (HDR) brachytherapy has been used in the treatment of prostate cancer since the 1980's with good results. Catheters are placed temporarily in the prostate, and then loaded with a high-dose Iridium-192 source, delivering a few fractions of very high-dose RT. Brachytherapy allows the delivery of conformal, high-dose radiotherapy to the prostate, with a rapid dose fall-off outside of the region. It also takes advantage of low alpha/beta ratio of prostate cancer by using a hypofractionated approach.
1.4 The TrueBeam is a noninvasive radiosurgical system, capable of treating any part of the body from multiple targeting angles, creating a highly conformal three-dimensional radiosurgical treatment volume, guided by orthogonal X-ray-based targeting feedback, and delivering radiation by a highly collimated, robotically controlled linear accelerator. The TrueBeam system targets implanted fiducial markers with sub-millimeter set-up accuracy.
1.5 From a dosimetry standpoint, TrueBeam Stereotactic radiosurgery is capable of producing a dose distribution comparable to that created by prostate HDR brachytherapy treatment, without the need for invasive transperineal catheters, anesthesia, or inpatient admission. It would therefore be possible to deliver the HDR boost portion of a patient's treatment in a non-invasive fashion. As such, the TrueBeam prostate dose fractionation schedule prescribed in this study is based upon prior published prostate HDR brachytherapy experience both as a monotherapy and as a boost to external beam radiation therapy in patients with higher risk disease. The therapeutic volume in this study will also be made to resemble prostate HDR brachytherapy therapeutic volume, with similar dose limitation objectives to the adjacent tissues, including the rectum, bladder and urethra. It is theorized that such an approach should result in similar cancer control rates while lowering overall morbidity and improving the patient's comfort and convenience.
1.6 The feasibility of stereotactic body radiation therapy for treating localized prostate cancer was first described by King at Stanford University. Their phase I protocol delivered 36.25Gy in 5 fractions of 7.25Gy. In a recent report of acute and 18-month late toxicity in 26 "low-risk" patients, no patient experienced grade 3 or 4 acute or late toxicity, and only one patient experienced a grade 2 late morbidity (urethral stricture). Toxicity was less than that reported in MD Anderson's external beam dose escalation trial. Mean PSA 18 months after treatment was 0.22ng/ml. Naples Community Hospital reported a series of more than 70 low and intermediate risk patients treated with the SBRT. The prostate received 35 Gy in 5 fractions of 7 Gy each; acute toxicity was minimal. San Diego Cyberknife, which used a virtual HDR technique, reported a series of more than 124 low and intermediate risk patients treated. The prostate received 38Gy in 4 fractions of 9.5Gy each; acute toxicity was minimal.
1.7 Another potential benefit of stereotactic body radiosurgery relative to HDR brachytherapy is possibly better preservation of potency, even if the radiation distribution is essentially identical between these modalities. This is so because needle trauma has been identified as a potentially significant contributory factor to erectile dysfunction with brachytherapy, including HDR-based monotherapy technique, presumably due to direct physical injury to the neurovascular bundle and/or bulb of the penis, particularly when greater than 13 needle insertions are performed. By comparison, stereotactic body radiosurgery is noninvasive, and so removes this particular erectile dysfunction risk factor.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic 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 RadiotherapyRadiation
Treatment of prostate cancer with stereotactic body radiation therapy (SBRT)
| Study group | Role | What they receive |
|---|---|---|
| Observation | Other | Observational study of patient efficacy and side effects Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Rate of disease recurrence locally
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start5 Jun 2018
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linda Chan, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Linda Chan, MD, MemorialCare Health System
- Investigators
- Linda Chan, MD, Principal investigator, Memorial Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552509
- Sponsor's protocol ID
- 790-17
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified MonoTherapy Versus RADIOSURGERY Boost
- ClinicalTrials.gov ID
- NCT04552509
- Acronym / sponsor ID
- 790-17
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Linda Chan, MDUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Sep 2020 (actual)
- 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 determine the effects of TrueBeam stereotactic body radiosurgery in patients with prostate cancer. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time. Radiosurgery is a non-invasive treatment technique used to treat tumors. Despite the word "surgery" in the name, the technology does not remove the tumor with a surgical knife. Instead, a focused, high-intensity beam of radiation targets the tumor, while minimizing dose to surrounding normal healthy tissue.
Detailed description
1.0 BACKGROUND 1.1 Prostatic adenocarcinoma is one of the most common forms of malignancy in men. Every year over 200000 patients are diagnosed with prostate cancer in the United States. Treatment options for these patients include active surveillance, radical prostectomy, external beam radiation therapy, permanent source interstitial brachytherapy and high dose rate (HDR) brachytherapy.
1.2 Each of these treatment options vary in regards to the logistics, anticipated outcomes, and potential side effects of therapy.
1.3 High-dose rate (HDR) brachytherapy has been used in the treatment of prostate cancer since the 1980's with good results. Catheters are placed temporarily in the prostate, and then loaded with a high-dose Iridium-192 source, delivering a few fractions of very high-dose RT. Brachytherapy allows the delivery of conformal, high-dose radiotherapy to the prostate, with a rapid dose fall-off outside of the region. It also takes advantage of low alpha/beta ratio of prostate cancer by using a hypofractionated approach.
1.4 The TrueBeam is a noninvasive radiosurgical system, capable of treating any part of the body from multiple targeting angles, creating a highly conformal three-dimensional radiosurgical treatment volume, guided by orthogonal X-ray-based targeting feedback, and delivering radiation by a highly collimated, robotically controlled linear accelerator. The TrueBeam system targets implanted fiducial markers with sub-millimeter set-up accuracy.
1.5 From a dosimetry standpoint, TrueBeam Stereotactic radiosurgery is capable of producing a dose distribution comparable to that created by prostate HDR brachytherapy treatment, without the need for invasive transperineal catheters, anesthesia, or inpatient admission. It would therefore be possible to deliver the HDR boost portion of a patient's treatment in a non-invasive fashion. As such, the TrueBeam prostate dose fractionation schedule prescribed in this study is based upon prior published prostate HDR brachytherapy experience both as a monotherapy and as a boost to external beam radiation therapy in patients with higher risk disease. The therapeutic volume in this study will also be made to resemble prostate HDR brachytherapy therapeutic volume, with similar dose limitation objectives to the adjacent tissues, including the rectum, bladder and urethra. It is theorized that such an approach should result in similar cancer control rates while lowering overall morbidity and improving the patient's comfort and convenience.
1.6 The feasibility of stereotactic body radiation therapy for treating localized prostate cancer was first described by King at Stanford University. Their phase I protocol delivered 36.25Gy in 5 fractions of 7.25Gy. In a recent report of acute and 18-month late toxicity in 26 "low-risk" patients, no patient experienced grade 3 or 4 acute or late toxicity, and only one patient experienced a grade 2 late morbidity (urethral stricture). Toxicity was less than that reported in MD Anderson's external beam dose escalation trial. Mean PSA 18 months after treatment was 0.22ng/ml. Naples Community Hospital reported a series of more than 70 low and intermediate risk patients treated with the SBRT. The prostate received 35 Gy in 5 fractions of 7 Gy each; acute toxicity was minimal. San Diego Cyberknife, which used a virtual HDR technique, reported a series of more than 124 low and intermediate risk patients treated. The prostate received 38Gy in 4 fractions of 9.5Gy each; acute toxicity was minimal.
1.7 Another potential benefit of stereotactic body radiosurgery relative to HDR brachytherapy is possibly better preservation of potency, even if the radiation distribution is essentially identical between these modalities. This is so because needle trauma has been identified as a potentially significant contributory factor to erectile dysfunction with brachytherapy, including HDR-based monotherapy technique, presumably due to direct physical injury to the neurovascular bundle and/or bulb of the penis, particularly when greater than 13 needle insertions are performed. By comparison, stereotactic body radiosurgery is noninvasive, and so removes this particular erectile dysfunction risk factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | Other | Radiation: Stereotactic Body RadiotherapyObservational study of patient efficacy and side effects |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven prostate adenocarcinoma
- Clinical Stage I-IV, MX-M0 (AJCC 6th Edition)
- Prostate volume: ≤ 100 cc (recommended not required)
- ECOG performance status 0-1
- Completion of patient questionnaires in section 4.7.
Key exclusion criteria (3 listed)
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- 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 RadiotherapyTreatment of prostate cancer with stereotactic body radiation therapy (SBRT) | Radiation | Observation |
Primary outcome
Local control
Time frame: 5 years
Rate of disease recurrence locally
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Linda Chan, MD principal investigator
Memorial Health Services
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 Radiotherapy in people with Prostate Cancer, run by Linda Chan, MD 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 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 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?
Local control (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 24 Aug 2026.