Prostate CancerPREPARE SBRTNCT03663218
PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
A study testing 5 Gy x 5 fractions, 6 Gy x 5 fractions and 6.5 Gy x 5 fractions in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 5 Gy x 5 fractions, 6 Gy x 5 fractions and 6.5 Gy x 5 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
- KPS greater than equal to 70
- Patient with a negative staging bone scan.
- Patient can undergo an MRI.
- Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required.
- Patient is medically fit to undergo prostatectomy.
- Patient has either Gleason Score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of T3 disease.
Who cannot join
- Prior history of receiving pelvic radiotherapy.
- Patient is unwilling to undergo prostatectomy.
- Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.
Trial locations and contacts
1 site in 1 country.
About this study
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.
Read the detailed description
Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single-arm study including two parts. Part 1 will be a modified dose escalation and de-escalation study to determine maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) based on acute toxicity measures. Part 2 will be a cohort expansion study to further evaluate the safety and tolerability of the RP2D based on toxicities measured at 1 year.
For Part 1, the primary endpoint is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative GU and/or GI grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days.
For Part 2, the primary endpoint is to assess GU and/or GI grade 3 or higher toxicity based on CTCAE v5.0 at 1 year.
The previously entered quality-of-life measure was removed to align the record with the primary and secondary endpoints as pre-specified in the IRB-approved protocol.
Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.
- Conditions
- Prostate Cancer
- Being tested
- 5 Gy x 5 fractions, 6 Gy x 5 fractions, 6.5 Gy x 5 fractions, maximum tolerated dose (6.5 Gy x 5 fractions), recommended phase 2 dose (6.5 Gy x 5 fractions)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Gy x 5 fractionsRadiation
In the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy).
6 Gy x 5 fractionsRadiation
In the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy).
6.5 Gy x 5 fractionsRadiation
In the arm "Part 1 - Arm 6.5 Gy x 5 fractions" the participants will receive a dose of 6.5 Gy for each RT fraction for a total of 5 fractions (total dose 32.5 Gy).
maximum tolerated dose (6.5 Gy x 5 fractions)Radiation
In the arm "Part 1 - MTD Expansion Cohort" participants will receive the dose established as the maximum tolerated dose (MTD) based on the previously tested dose levels.
recommended phase 2 dose (6.5 Gy x 5 fractions)Radiation
In the arm "Part 2 - Arm RP2D" participants will receive the dose established as the recommended phase 2 dose (RP2D) based on the previously tested dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Arm 5 Gy x 5 fractions | Other | Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs.
In the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy). Receives: Radiation: 5 Gy x 5 fractions |
| Part 1 - Arm 6 Gy x 5 fractions | Other | Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs.
In the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy). Receives: Radiation: 6 Gy x 5 fractions |
| Part 1 - Arm 6.5 Gy x 5 fractions | Other | Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs.
In the arm "Part 1 - Arm 6.5 Gy x 5 fractions" the participants will receive a dose of 6.5 Gy for each RT fraction for a total of 5 fractions (total dose 32.5 Gy). Receives: Radiation: 6.5 Gy x 5 fractions |
| Part 1 - ARM MTD expansion cohort | Other | Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs.
In the arm "Part 1 - MTD Expansion Cohort" participants will receive the dose established as the maximum tolerated dose (MTD) based on the previously tested dose levels. Receives: Radiation: maximum tolerated dose (6.5 Gy x 5 fractions) |
| Part 2 - Arm RP2D | Other | In part 2 of the study, additional 21 patients will be enrolled to further examine the safety of the R2PD in a total of 30 patients. The primary safety endpoint will be G2+ GI and/or GU AEs related to preoperative radiotherapy according to the CTCAE v5.0 measured at 1 year. Patients will be continuously monitored to ensure the acute G3+ GU and/or GI AEs based on the Clavien-Dindo Classification at 30 days do not exceed 4 of 18 patients, and 6 of 27 patients.
In the arm "Part 2 - Arm RP2D" participants will receive the dose established as the recommended phase 2 dose (RP2D) based on the previously tested dose levels. Receives: Radiation: recommended phase 2 dose (6.5 Gy x 5 fractions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Successfully Complete Radical Prostatectomy After SBRT Without a Post-operative DLT of Grade 3 or Higher (Part 1)
Part 1: Successful completion of radical prostatectomy after SBRT without a post-operative dose limiting toxicity (DLT) of grade 3 or higher within 1 month after prostatectomy according to the Clavien-Dindo Classification.
Measured: 1 month
Number of Gastric-intestinal (GI) and/or Genitor-urinary (GU) Adverse Events Equal or Higher G3 Related to Preoperative Radiotherapy According to the CTCAE v5.0 Measured at 1 Year (Part 2)
Part 2: Successful completion of radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher within 1 year after prostatectomy.
Measured: 1 year
Secondary outcomes (1)
Acute Toxicity in Patients After Stereotactic Body Radiotherapy (SBRT) and Radical Prostatectomy (RP) Will be Assessed Based on NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Part 2).
Acute toxicity in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be assessed based on NCI Common terminology criteria for adverse events (CTCAE) version 5.0.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start24 Oct 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia C. Formenti, M.D., Principal investigator, Weill Cornell Medicine - New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663218
- Sponsor's protocol ID
- 1712018849
- Acronym
- PREPARE SBRT
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2018
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
- ClinicalTrials.gov ID
- NCT03663218
- Acronym / sponsor ID
- PREPARE SBRT / 1712018849
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.
Detailed description
Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single-arm study including two parts. Part 1 will be a modified dose escalation and de-escalation study to determine maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) based on acute toxicity measures. Part 2 will be a cohort expansion study to further evaluate the safety and tolerability of the RP2D based on toxicities measured at 1 year.
For Part 1, the primary endpoint is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative GU and/or GI grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days.
For Part 2, the primary endpoint is to assess GU and/or GI grade 3 or higher toxicity based on CTCAE v5.0 at 1 year.
The previously entered quality-of-life measure was removed to align the record with the primary and secondary endpoints as pre-specified in the IRB-approved protocol.
Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Arm 5 Gy x 5 fractions | Other | Radiation: 5 Gy x 5 fractionsPart 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs. In the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy). |
| Part 1 - Arm 6 Gy x 5 fractions | Other | Radiation: 6 Gy x 5 fractionsPart 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs. In the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy). |
| Part 1 - Arm 6.5 Gy x 5 fractions | Other | Radiation: 6.5 Gy x 5 fractionsPart 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs. In the arm "Part 1 - Arm 6.5 Gy x 5 fractions" the participants will receive a dose of 6.5 Gy for each RT fraction for a total of 5 fractions (total dose 32.5 Gy). |
| Part 1 - ARM MTD expansion cohort | Other | Radiation: maximum tolerated dose (6.5 Gy x 5 fractions)Part 1 uses a modified 3+3 dose escalation/de-escalation design with expansion to define the RP2D in a minimum of 3 to a maximum of 9 patients. DLT is defined as Grade ≥3 GI and/or GU toxicity related to preoperative radiotherapy per Clavien-Dindo within 30 days. Three dose levels are evaluated: 5 Gy, 6 Gy, and 6.5 Gy. At each level, 3 patients are treated over five days. If 0/3 experience DLT, escalate. If 1/3 has DLT, expand to 6. If ≤1/6 have DLT, escalate; if ≥2/6, de-escalate and define the prior dose as MTD. The MTD is expanded to 9 patients. If ≤2/9 have DLT, it is the RP2D; if ≥3/9, further de-escalation occurs. In the arm "Part 1 - MTD Expansion Cohort" participants will receive the dose established as the maximum tolerated dose (MTD) based on the previously tested dose levels. |
| Part 2 - Arm RP2D | Other | Radiation: recommended phase 2 dose (6.5 Gy x 5 fractions)In part 2 of the study, additional 21 patients will be enrolled to further examine the safety of the R2PD in a total of 30 patients. The primary safety endpoint will be G2+ GI and/or GU AEs related to preoperative radiotherapy according to the CTCAE v5.0 measured at 1 year. Patients will be continuously monitored to ensure the acute G3+ GU and/or GI AEs based on the Clavien-Dindo Classification at 30 days do not exceed 4 of 18 patients, and 6 of 27 patients. In the arm "Part 2 - Arm RP2D" participants will receive the dose established as the recommended phase 2 dose (RP2D) based on the previously tested dose levels. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
- KPS greater than equal to 70
- Patient with a negative staging bone scan.
- Patient can undergo an MRI.
- Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required.
Key exclusion criteria (3 listed)
- Prior history of receiving pelvic radiotherapy.
- Patient is unwilling to undergo prostatectomy.
- Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.
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 |
|---|---|---|
| 5 Gy x 5 fractionsIn the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy). | Radiation | Part 1 - Arm 5 Gy x 5 fractions |
| 6 Gy x 5 fractionsIn the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy). | Radiation | Part 1 - Arm 6 Gy x 5 fractions |
| 6.5 Gy x 5 fractionsIn the arm "Part 1 - Arm 6.5 Gy x 5 fractions" the participants will receive a dose of 6.5 Gy for each RT fraction for a total of 5 fractions (total dose 32.5 Gy). | Radiation | Part 1 - Arm 6.5 Gy x 5 fractions |
| maximum tolerated dose (6.5 Gy x 5 fractions)In the arm "Part 1 - MTD Expansion Cohort" participants will receive the dose established as the maximum tolerated dose (MTD) based on the previously tested dose levels. | Radiation | Part 1 - ARM MTD expansion cohort |
| recommended phase 2 dose (6.5 Gy x 5 fractions)In the arm "Part 2 - Arm RP2D" participants will receive the dose established as the recommended phase 2 dose (RP2D) based on the previously tested dose levels. | Radiation | Part 2 - Arm RP2D |
Primary outcome
Number of Subjects Who Successfully Complete Radical Prostatectomy After SBRT Without a Post-operative DLT of Grade 3 or Higher (Part 1)
Time frame: 1 month
Part 1: Successful completion of radical prostatectomy after SBRT without a post-operative dose limiting toxicity (DLT) of grade 3 or higher within 1 month after prostatectomy according to the Clavien-Dindo Classification.
Number of Gastric-intestinal (GI) and/or Genitor-urinary (GU) Adverse Events Equal or Higher G3 Related to Preoperative Radiotherapy According to the CTCAE v5.0 Measured at 1 Year (Part 2)
Time frame: 1 year
Part 2: Successful completion of radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher within 1 year after prostatectomy.
1 secondary outcome
Acute Toxicity in Patients After Stereotactic Body Radiotherapy (SBRT) and Radical Prostatectomy (RP) Will be Assessed Based on NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Part 2).
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Silvia C. Formenti, M.D. principal investigator
Weill Cornell Medicine - New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 Gy x 5 fractions, 6 Gy x 5 fractions and 6.5 Gy x 5 fractions in people with Prostate Cancer, run by Weill Medical College of Cornell University 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 7 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 18 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 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?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Successfully Complete Radical Prostatectomy After SBRT Without a Post-operative DLT of Grade 3 or Higher (Part 1) (time frame: 1 month). The study lists 2 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 18 Mar 2026.