Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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
Exclusion Criteria
- •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
- •Prior history of urethral stricture
- •Unable to give informed consent
- •Unable to complete quality of life questionnaires
Arms & Interventions
MRI-Linac-based SBRT with online adaptive replanning
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).
Intervention: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
MRI-Linac-based SBRT with online adaptive replanning
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).
Intervention: Androgen Deprivation Therapy (ADT) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- International prostate symptom score index (IPSS) score(Month 24)
- International Index of Erectile Function (IIEF) score(Month 24)