Intraprostatic Prostate CancerNCT07142967
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
A study testing Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) in people with Intraprostatic 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 prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intraprostatic Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 2 Aug 2030
- 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
- 18 years of age or older male participants
- Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable).
- NOTE: Seminal vesicle involvement allowed
- Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned
- Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment
- Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level >50ng/dL
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- At least 4 weeks must have elapsed from major surgery
- Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1
- Prostate size as determined on MRI to be < 90 cc.
- International Prostatism Symptom Score (IPSS) ≤ 20
- Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years
- Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI
- NOTE: Lesion visible on MRI required for enrollment but PSMA/PET avid lesion not required
- Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
Who cannot join
- History of prostate brachytherapy (low dose rate or high dose rate)
- Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment
- CT or MRI or PET scan evidence of extraprostatic disease
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
- Patients with Crohn's disease or ulcerative colitis
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- 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 MRCAT reconstruction
- Contra-indications to receiving gadolinium contrast or PSMA radioligand
- Karnofsky Performance Scale (KPS) < 80 or ECOG 2+
- Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT)
- Disease free interval < 2 years
- Hx of Transurethral Resection Of Prostate (TURP) within the year
- Prior high-intensity focused ultrasound (HIFU) or Cryotherapy
- Prior history of urethral stricture
- Unable to give informed consent
- Unable to complete quality of life questionnaires
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
The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.
- Conditions
- Intraprostatic Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Androgen Deprivation Therapy (ADT)
- Keywords
- prostate adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
SBRT will be delivered with a prescription dose of 8 Gy x 5 fractions prescribed to the 95% isodose line encompassing the dominant recurrent intraprostatic lesion (DRIL) as seen on MRI and/or PET PSMA imaging plus 4mm (GTV+4mm=CTV_40). Remainder of the prostate gland minus CTV_40 (CTV_25) will be prescribed to 5 Gy x 5 fractions at the 95% isodose line.
Androgen Deprivation Therapy (ADT)Drug
ADT would be given 0-1 months prior to planned SBRT to the prostate for total of 4-6 months. ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.
| Study group | Role | What they receive |
|---|---|---|
| MRI-Linac-based SBRT with online adaptive replanning | Experimental | Participants will be treated with MR-guided stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate using a 1.5 Tesla (1.5T) Elekta UNITY MR-Linac system in conjunction with 4-6 months of androgen deprivation therapy (ADT). Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events
A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0.
Measured: Month 24
Secondary outcomes (7)
Acute toxicity (occurring within 90 days of the treatment) radiation-associated genitourinary (GU) and gastrointestinal (GI) events
A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0.
Measured: Month 24
Biochemical progression free survival
From the time after treatment until the prostate-specific antigen (PSA) level rises, indicating a potential return of cancer.
Measured: Month 24
Distant metastasis-free survival (DMFS)
Distant metastasis-free survival (DMFS) the time from end of treatment until the first instance of distant metastasis or death, whichever occurs first.
Measured: Month 24
Radiographic treatment response rate of target intra-prostatic lesion
Radiographic treatment response rate is the patients whose tumors show a reduction in size or other measurable changes on imaging scans after receiving treatment.
Measured: Month 24
Expanded Prostate cancer Index Composite (EPIC-26) Short Form score
The EPIC-26 short form scores range from 0 to 100 for each of its five domains (urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal). Higher scores indicate better health-related quality of life (HRQOL) within that domain.
Measured: Month 24
International prostate symptom score index (IPSS) score
The IPSS index is a seven-item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six-point Likert scale, scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Scores are categorized as mild (0-7), moderate (8-19), or severe (20-35).
Measured: Month 24
International Index of Erectile Function (IIEF) score
The IIEF 5 form is a 5-item questionnaire used to assess erectile function and diagnose erectile dysfunction (ED). Participant rate their responses using a 6-point Likert Scale (0-5). Scores range from 5 to 25. Scores are categorized as follows: 5-7 (severe ED), 8-11 (moderate ED), 12-16 (mild to moderate ED), 17-21 (mild ED), and 22-25 (no ED)
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion2 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraprostatic 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zelefsky, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142967
- Sponsor's protocol ID
- 24-00856
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2025
- Last updated
- 10 Jul 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 will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Michael.zelefsky@nyulangone. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
- ClinicalTrials.gov ID
- NCT07142967
- Acronym / sponsor ID
- 24-00856
- Conditions
- Intraprostatic Prostate Cancer
- Keywords
- prostate adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 2 Aug 2030 (estimated)
- First posted
- 27 Aug 2025 (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 prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-Linac-based SBRT with online adaptive replanning | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: Androgen Deprivation Therapy (ADT)Participants will be treated with MR-guided stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate using a 1.5 Tesla (1.5T) Elekta UNITY MR-Linac system in conjunction with 4-6 months of androgen deprivation therapy (ADT). |
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)
- 18 years of age or older male participants
- Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable).
- Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned
- Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment
- At least 4 weeks must have elapsed from major surgery
Key exclusion criteria (18 listed)
- History of prostate brachytherapy (low dose rate or high dose rate)
- Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment
- CT or MRI or PET scan evidence of extraprostatic disease
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
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 Radiation Therapy (SBRT)SBRT will be delivered with a prescription dose of 8 Gy x 5 fractions prescribed to the 95% isodose line encompassing the dominant recurrent intraprostatic lesion (DRIL) as seen on MRI and/or PET PSMA imaging plus 4mm (GTV+4mm=CTV_40). Remainder of the prostate gland minus CTV_40 (CTV_25) will be prescribed to 5 Gy x 5 fractions at the 95% isodose line. | Radiation | MRI-Linac-based SBRT with online adaptive replanning |
| Androgen Deprivation Therapy (ADT)ADT would be given 0-1 months prior to planned SBRT to the prostate for total of 4-6 months. ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills. | Drug | MRI-Linac-based SBRT with online adaptive replanning |
Primary outcome
Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events
Time frame: Month 24
A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0.
7 secondary outcomes
Acute toxicity (occurring within 90 days of the treatment) radiation-associated genitourinary (GU) and gastrointestinal (GI) events
Time frame: Month 24
Biochemical progression free survival
Time frame: Month 24
Distant metastasis-free survival (DMFS)
Time frame: Month 24
Radiographic treatment response rate of target intra-prostatic lesion
Time frame: Month 24
Expanded Prostate cancer Index Composite (EPIC-26) Short Form score
Time frame: Month 24
International prostate symptom score index (IPSS) score
Time frame: Month 24
International Index of Erectile Function (IIEF) score
Time frame: Month 24
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 10 Jul 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Michael.zelefsky@nyulangone. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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, MD 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 Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) in people with Intraprostatic 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 14 inclusion and 18 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 10 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 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, MD (646-239-9083, Michael.zelefsky@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events (time frame: Month 24). 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 10 Jul 2026.