What this study is
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.
What's being tested
- 1.5 T Elekta Unity MR-Linac system
Intervention · RADIATION
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)
Intervention · 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 details
- 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)
- Sponsor
- NYU Langone Health
- Conditions
- Prostate Cancer
- Enrolling
- 91 people
- Starts
- 2024-12-09
- Est. completion
- 2029-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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
- 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
You can't join if
- 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
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openNYU Langone Health
New York, New York, United States
Recruiting
Study team
Sponsor
NYU Langone Health
Study ID 23-01590
Principal investigator
Michael Zelefsky, M.D
NYU Langone Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.