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

Launched by NYU LANGONE HEALTH · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat prostate cancer called MR-guided radiotherapy. The goal is to see how well this treatment controls the main tumor in the prostate for men with intermediate-risk prostate cancer. Participants will receive a special type of radiation therapy that targets not only the entire prostate but also delivers a higher dose to the most significant tumor area, identified through advanced MRI scans. By using these detailed images, doctors can tailor the treatment more precisely to the patient's needs.

To join the study, participants must be men aged 18 or older with intermediate-risk prostate cancer, which means they have certain levels of a blood marker called PSA or specific tumor characteristics. They should also be in good overall health and able to tolerate the MRI process. Throughout the trial, participants will undergo regular imaging and assessments to monitor how well the treatment is working. It's important to note that individuals with certain medical conditions or previous treatments for prostate cancer may not be eligible. This trial is currently recruiting participants, and those interested should talk to their healthcare provider for more information.

Gender

MALE

Eligibility 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)