Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)

NCT07142967 | Recruiting DMC FDA Device

• 1 other identifier: 24-00856
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

prostate adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 24

Secondary Outcomes (7)

• Acute toxicity (occurring within 90 days of the treatment) radiation-associated genitourinary (GU) and gastrointestinal (GI) events

  Month 24

• Biochemical progression free survival

  Month 24

• Distant metastasis-free survival (DMFS)

  Month 24

• Radiographic treatment response rate of target intra-prostatic lesion

  Month 24

• Expanded Prostate cancer Index Composite (EPIC-26) Short Form score

  Month 24

Study Arms (1)

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).

Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Androgen Deprivation Therapy (ADT)

Interventions

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.

MRI-Linac-based SBRT with online adaptive replanning

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.

MRI-Linac-based SBRT with online adaptive replanning

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• a. 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
• a. Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level \>50ng/dL
• 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
• a. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Radiosurgery; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Michael Zelefsky, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Zelefsky, MD

CONTACT

646-239-9083; Michael.zelefsky@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 2, 2030
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Michael.zelefsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)