Prostate CancerPhase 1NCT05864196
Two Fraction Prostate SBRT With DIL SIB
A Phase 1 study testing Two-Fraction Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Cancer, run by NYU Langone Health at 2 sites in United States.
Trial summary
Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. 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?
- Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jul 2023to Jun 2030
- Phase
- Phase 1
- 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
- Patient age greater than or equal 18
- Localized adenocarcinoma of the prostate
- Biopsy-proven diagnosis of prostate adenocarcinoma
- Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease
- TX-T2c-8th addition staging
- PSA<20 ng/ml
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- Grade group 3 or less
- Proper rectal space replacement required as determined by the treating radiation oncologist
- Prostate size less than 60cc defined at time of simulation based on MRI
- Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion
- -- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized
- Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
- Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
- Ability to give informed consent
Who cannot join
- High risk disease
- Pelvic lymph node involvement
- Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
- Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
- Prior radiation to the pelvis
- Prior malignancies within the last 5 years
Show all 14Show fewer
- Inability to meet pre-specified 2 fraction DVH constraints
- Prostate size > 60cc as measures at treatment planning MRI
- Active significant inflammatory bowel disease (IBD) or rheumatological disease
- Prior prostate surgeries
- Previous uro lift
- Transurethral resection of the prostate (TURP) within 6 months of SBRT
- "Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (>50 overall summary score for each domain)
- Men of reproductive potential may not participate unless they agree to use an effective contraceptive method
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
- Recruiting
NYCyberKnife at Perlmutter Cancer Center
New York, New York, 10016
About this study
Official title: A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer
Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- Prostate Cancer,SBRT,Radiation Treatment,CyberKnife, SBRT, Radiation Treatment, CyberKnife
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Fraction Stereotactic Body Radiation Therapy (SBRT)Radiation
Two-fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Men with low to intermediate risk prostate cancer | Experimental | Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5. Receives: Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to year 5 Post-Treatment
Secondary outcomes (6)
Nadir Prostate-Specific Antigen (nPSA) Levels
nPSA measured in ng/ml.
Measured: Up to Year 5 Post-Treatment
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
61-item assessment of quality of life in prostate cancer patients. The total score is the sum of responses and ranges from 0 to 301; higher scores indicate greater quality of life.
Measured: Baseline, Year 5 Post-Treatment
Incidence of Phoenix Definition Biomechanical Failure (BCF)
BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).
Measured: Up to Year 5 Post-Treatment
Disease-Free Survival (DFS)
The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer.
Measured: Up to Year 5 Post-Treatment
Overall Survival (OS)
The length of time after SBRT treatment that a patient survives.
Measured: Up to Year 5 Post-Treatment
Metastasis-Free Survival (MFS)
The length of time after SBRT treatment that a patient is still alive and the cancer has not spread to other parts of the body.
Measured: Up to Year 5 Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start17 Jul 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (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.
- More trials run by NYU Langone HealthThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Lischalk, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864196
- Sponsor's protocol ID
- 22-01306
- Status last verified
- Jan 2026
- First submitted
- 9 May 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[Vianca.santos@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05864196
- Acronym / sponsor ID
- 22-01306
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer,SBRT,Radiation Treatment,CyberKnife, SBRT, Radiation Treatment, CyberKnife
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 18 May 2023 (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.
Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with low to intermediate risk prostate cancer | Experimental | Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient age greater than or equal 18
- Localized adenocarcinoma of the prostate
- Biopsy-proven diagnosis of prostate adenocarcinoma
- Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease
- Proper rectal space replacement required as determined by the treating radiation oncologist
Key exclusion criteria (14 listed)
- High risk disease
- Pelvic lymph node involvement
- Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
- Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
- Prior radiation to the pelvis
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 |
|---|---|---|
| Two-Fraction Stereotactic Body Radiation Therapy (SBRT)Two-fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. | Radiation | Men with low to intermediate risk prostate cancer |
Primary outcome
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Time frame: Up to year 5 Post-Treatment
Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
6 secondary outcomes
Nadir Prostate-Specific Antigen (nPSA) Levels
Time frame: Up to Year 5 Post-Treatment
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
Time frame: Baseline, Year 5 Post-Treatment
Incidence of Phoenix Definition Biomechanical Failure (BCF)
Time frame: Up to Year 5 Post-Treatment
Disease-Free Survival (DFS)
Time frame: Up to Year 5 Post-Treatment
Overall Survival (OS)
Time frame: Up to Year 5 Post-Treatment
Metastasis-Free Survival (MFS)
Time frame: Up to Year 5 Post-Treatment
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 29 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Vianca.santos@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jonathan Lischalk principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Two-Fraction Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Cancer, run by NYU Langone Health at 2 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 14 inclusion and 14 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Vianca Santos, MPH (212-496-5845, Vianca.santos@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0 (time frame: Up to year 5 Post-Treatment). 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 29 Jan 2026.