Prostate CancerPhase 1NCT03269422
Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
A Phase 1 study testing MR-based image-guided, intensity-modulated radiotherapy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate 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?
- MR-based image-guided, intensity-modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2017to 29 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate risk patients will be defined as:
- PSA 10-20 ng/ml or
- Gleason score = 7 or
- Clinical stage T2b/T2c
- Additionally, patients will be required to meet the following criteria:
- Age >18
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- KPS > 80
- Prostate size < 60cc
- Presence of a prostatic lesion with maximum dimension of >/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
- International Prostrate Symptom Score < 15
- Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria
Who cannot join
- Prior androgen deprivation therapy for prostate cancer
- Evidence of metastatic disease on bone scan or MRI/CT
- MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
- Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
- Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
- Contra-indications to receiving gadolinium contrast
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- KPS < 80
- Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.
- Prior history of transurethral resection of the prostate
- Prior history of chronic prostatitis
- Prior history of urethral stricture
- Prior history of pelvic irradiation
- History of inflammatory bowel disease
- Unable to give informed consent
- Unable to complete quality of life questionnaires
- Abnormal complete blood count. Any of the following
- Platelet count less than 75,000/ml
- Hb level less than 10 gm/dl
- WBC less than 3.5/ml
- Abnormal renal function tests (creatinine > 1.5)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and follow up)
Uniondale, New York, 11553
About this study
Official title: A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy
The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.
- Conditions
- Prostate Cancer
- Being tested
- MR-based image-guided, intensity-modulated radiotherapy
- Keywords
- 17-407, Intermediate Risk Prostate Cancer, DIL, Dominant Intra-Prostatic Lesion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-based image-guided, intensity-modulated radiotherapyRadiation
Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging.
| Study group | Role | What they receive |
|---|---|---|
| MR Image Guided, Intensity-Modulated Radiotherapy | Experimental | Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC. Receives: Radiation: MR-based image-guided, intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start28 Aug 2017
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
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 Memorial Sloan Kettering 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Gorovets, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269422
- Sponsor's protocol ID
- 17-407
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2017
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy
- ClinicalTrials.gov ID
- NCT03269422
- Acronym / sponsor ID
- 17-407
- Conditions
- Prostate Cancer
- Keywords
- 17-407, Intermediate Risk Prostate Cancer, DIL, Dominant Intra-Prostatic Lesion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 31 Aug 2017 (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 the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR Image Guided, Intensity-Modulated Radiotherapy | Experimental | Radiation: MR-based image-guided, intensity-modulated radiotherapyPatients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate risk patients will be defined as:
- Additionally, patients will be required to meet the following criteria:
Key exclusion criteria (20 listed)
- Prior androgen deprivation therapy for prostate cancer
- Evidence of metastatic disease on bone scan or MRI/CT
- MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
- Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
- Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
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 |
|---|---|---|
| MR-based image-guided, intensity-modulated radiotherapyPatients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging. | Radiation | MR Image Guided, Intensity-Modulated Radiotherapy |
Primary outcome
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Time frame: 36 months
Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Gorovets, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 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 MR-based image-guided, intensity-modulated radiotherapy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 11 inclusion and 20 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: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity (time frame: 36 months). 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 31 Jul 2026.