Prostate CancerNCT06542757
Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy
A study testing 1.5 T Elekta Unity MR-Linac system and Hydrogel rectal spacer (SpaceOAR) in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk 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?
- 1.5 T Elekta Unity MR-Linac system and Hydrogel rectal spacer (SpaceOAR)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to Dec 2029
- 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
- Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:
- PSA 10-20 ng/ml or
- Gleason score = 7 or
- Clinical stage T2b/T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate)
- Age > 18
- Karnofsky Performance Status (KPS) > 80
Show all 11Show fewer
- Prostate size < 90 cc
- Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion
- MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
- International Prostate Symptom Score < 18
- Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
Who cannot join
- Gleason score >7
- PSA >20 ng/mL
- Prior or concurrent androgen deprivation therapy for prostate cancer
- MRI findings: suspicious for/probable ECE
- MRI findings: >2 disease foci identifiable
- Evidence of metastatic disease on bone scan or MRI/CT
Show all 23Show fewer
- 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; inability to lie flat for the duration of the study; etc.
- 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 MR for Calculating ATtenuation (MRCAT) reconstruction
- Contra-indications to receiving gadolinium contrast
- KPS < 80
- Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
- Prior history of transurethral resection of the prostate
- 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, including any of the following:
- Platelet count less than 75,000/ml
- Hb level less than 10 gm/dl
- White blood cell (WBC) less than 3.5/ml
- Abnormal renal function tests (creatinine > 1.5)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy (TUMORNATOR I)
The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.
- Conditions
- Prostate Cancer
- Being tested
- 1.5 T Elekta Unity MR-Linac system, Hydrogel rectal spacer (SpaceOAR)
- Keywords
- intensity-modulated radiotherapy, MR-guided
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 T Elekta Unity MR-Linac systemRadiation
Patients will receive 9 Gy/fraction (45 Gy total) for five fractions to the DIL, while the remainder of the prostate will be treated to 30 Gy in 5 fractions.
Hydrogel rectal spacer (SpaceOAR)Device
A rectal spacer will be placed one week prior to simulation to achieve a separation of approximately 1 cm between the prostate and anterior rectal wall to further minimize rectal toxicity in these patients. The hydrogel will remain in the body for about 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided Intensity Modulated Radiotherapy | Experimental | All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks). Receives: Radiation: 1.5 T Elekta Unity MR-Linac system; Device: Hydrogel rectal spacer (SpaceOAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative biopsy rate 24 months post-treatment
Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI
Measured: 24 months post-treatment
Serious toxicity rate 24 months post-treatment
Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity.
Measured: 24 months post-treatment
Secondary outcomes (11)
Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment
Measured: 24 months post-treatment
Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment
Outcome measure will be assessed using multi-parametric MR imaging.
Measured: 6 months post-treatment
Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment
Outcome measure will be assessed using multi-parametric MR imaging.
Measured: 24 months post-treatment
Change in International Prostate Symptom Score (I-PSS)
The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic.
Measured: Baseline, Month 3
Change in International Prostate Symptom Score (I-PSS)
The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic.
Measured: Baseline, Month 6
Change in International Prostate Symptom Score (I-PSS)
The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic.
Measured: Baseline, Month 12-18
Change in International Index of Erectile Function (IIEF) score
The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. Erectile dysfunction (ED) severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7).
Measured: Baseline, Month 3
Change in International Index of Erectile Function (IIEF) score
The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. ED severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7).
Measured: Baseline, Month 6
Change in International Index of Erectile Function (IIEF) score
The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. ED severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7).
Measured: Baseline, Month 12-18
Change in genomic classifier (GC) Decipher score
Scores are derived from the expression of 22 genes. Decipher scores are a continuous variable reported on a scale of 0 to 1. These scores are then stratified to three risk-categories: low (<0.45), intermediate (≥ 0.45 - < 0.6) and high (≥ 0.6)
Measured: Baseline, 6 months post-treatment
Change in GC Decipher score
Scores are derived from the expression of 22 genes. Decipher scores are a continuous variable reported on a scale of 0 to 1. These scores are then stratified to three risk-categories: low (<0.45), intermediate (≥ 0.45 - < 0.6) and high (≥ 0.6)
Measured: Baseline, 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start9 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zelefsky, M.D, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542757
- Sponsor's protocol ID
- 23-01590
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared to achieve aims in the approved proposal beginning 3 months and ending 5 years following article publication provided the researchers who provide a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: Michael.Zelefsky@nyulangone.org. The protocol, statistical analysis plan, informed consent form, and clinical study report 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy (TUMORNATOR I)
- ClinicalTrials.gov ID
- NCT06542757
- Acronym / sponsor ID
- 23-01590
- Conditions
- Prostate Cancer
- Keywords
- intensity-modulated radiotherapy, MR-guided
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 Aug 2024 (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 assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided Intensity Modulated Radiotherapy | Experimental | Radiation: 1.5 T Elekta Unity MR-Linac system, Device: Hydrogel rectal spacer (SpaceOAR)All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks). |
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 National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:
- Age > 18
- Karnofsky Performance Status (KPS) > 80
- Prostate size < 90 cc
- Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion
Key exclusion criteria (23 listed)
- Gleason score >7
- PSA >20 ng/mL
- Prior or concurrent androgen deprivation therapy for prostate cancer
- MRI findings: suspicious for/probable ECE
- MRI findings: >2 disease foci identifiable
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 |
|---|---|---|
| 1.5 T Elekta Unity MR-Linac systemPatients will receive 9 Gy/fraction (45 Gy total) for five fractions to the DIL, while the remainder of the prostate will be treated to 30 Gy in 5 fractions. | Radiation | MRI-guided Intensity Modulated Radiotherapy |
| Hydrogel rectal spacer (SpaceOAR)A rectal spacer will be placed one week prior to simulation to achieve a separation of approximately 1 cm between the prostate and anterior rectal wall to further minimize rectal toxicity in these patients. The hydrogel will remain in the body for about 12 weeks. | Device | MRI-guided Intensity Modulated Radiotherapy |
Primary outcome
Negative biopsy rate 24 months post-treatment
Time frame: 24 months post-treatment
Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI
Serious toxicity rate 24 months post-treatment
Time frame: 24 months post-treatment
Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity.
11 secondary outcomes
Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment
Time frame: 24 months post-treatment
Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment
Time frame: 6 months post-treatment
Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment
Time frame: 24 months post-treatment
Change in International Prostate Symptom Score (I-PSS)
Time frame: Baseline, Month 3
Change in International Prostate Symptom Score (I-PSS)
Time frame: Baseline, Month 6
Change in International Prostate Symptom Score (I-PSS)
Time frame: Baseline, Month 12-18
Change in International Index of Erectile Function (IIEF) score
Time frame: Baseline, Month 3
Change in International Index of Erectile Function (IIEF) score
Time frame: Baseline, Month 6
Change in International Index of Erectile Function (IIEF) score
Time frame: Baseline, Month 12-18
Change in genomic classifier (GC) Decipher score
Time frame: Baseline, 6 months post-treatment
Change in GC Decipher score
Time frame: Baseline, 24 months 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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared to achieve aims in the approved proposal beginning 3 months and ending 5 years following article publication provided the researchers who provide a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: Michael.Zelefsky@nyulangone.org. The protocol, statistical analysis plan, informed consent form, and clinical study report 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.
Michael Zelefsky, M.D principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5 T Elekta Unity MR-Linac system and Hydrogel rectal spacer (SpaceOAR) in people with Prostate Cancer, run by NYU Langone Health 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 11 inclusion and 23 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 11 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?
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 Michael Zelefsky, M.D (212-263-4432, CancerTrials@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative biopsy rate 24 months post-treatment (time frame: 24 months post-treatment). 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 11 Mar 2026.