Evaluating MRI-guided radiotherapy for prostate cancer treatment
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)
This study is testing if a new type of MRI-guided radiation therapy can help control tumors better in men with intermediate-risk prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 91 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06542757 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness of MR-guided radiotherapy in controlling tumors in patients with intermediate-risk prostate cancer. It utilizes a technique called ultra-hypofractionated external beam radiation therapy, which includes a high-dose boost to the dominant intraprostatic lesion identified through multiparametric MRI. The approach aims to optimize treatment by adapting radiation delivery based on real-time imaging, potentially improving outcomes for patients. The study will monitor tumor control following this innovative treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 18 with intermediate-risk prostate cancer as defined by specific clinical criteria.
Not a fit: Patients with low-risk or high-risk prostate cancer, or those with significant comorbidities affecting treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved tumor control and outcomes for patients with intermediate-risk prostate cancer.
How similar studies have performed: Other studies utilizing MR-guided radiotherapy have shown promising results, suggesting that this approach may be effective in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 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)
2. Age \> 18
3. Karnofsky Performance Status (KPS) \> 80
4. Prostate size \< 90 cc
5. 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
6. MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
7. International Prostate Symptom Score \< 18
8. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
Exclusion Criteria:
1. Gleason score \>7
2. PSA \>20 ng/mL
3. Prior or concurrent androgen deprivation therapy for prostate cancer
4. MRI findings: suspicious for/probable ECE
5. MRI findings: \>2 disease foci identifiable
6. Evidence of metastatic disease on bone scan or MRI/CT
7. 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.
8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
9. 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
10. Contra-indications to receiving gadolinium contrast
11. KPS \< 80
12. Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
13. Prior history of transurethral resection of the prostate
14. Prior history of urethral stricture
15. Prior history of pelvic irradiation
16. History of inflammatory bowel disease
17. Unable to give informed consent
18. Unable to complete quality of life questionnaires
19. 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)
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael Zelefsky, M.D — NYU Langone Health
- Study coordinator: Michael Zelefsky, M.D
- Email: CancerTrials@nyulangone.org
- Phone: 212-263-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.