A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Aug 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat intermediate-risk prostate cancer using a special type of radiation therapy called MRI-guided high-dose radiation therapy. The goal is to see if giving a higher dose of radiation directly to the main tumor, along with a standard dose to the rest of the prostate, can help cure the cancer or prevent it from coming back longer than current treatments, while also minimizing side effects.

To be eligible for this study, participants must be adult men (18 years or older) with intermediate-risk prostate cancer, which is defined by specific measures like their PSA level or Gleason score. Participants should be in good overall health, with a Karnofsky Performance Status of 80 or higher, meaning they can carry out most daily activities without assistance. They will undergo MRI scans to ensure they meet the criteria for the trial. Those who qualify can expect to receive targeted radiation therapy and will be monitored for their health and quality of life throughout the study. It’s important to note that certain conditions, like a higher Gleason score or prior treatments, may exclude individuals from participating.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• * Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:
• • PSA 10-20 ng/ml or
• • Gleason score = 7 or
• • Clinical stage T2b/T2c or
• * Additionally, patients will be required to meet all of the following criteria:
• • Age ≥ 18
• • Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)
• • Prostate size ≤ 80 cc
• • Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus
• • MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
• • International Prostate Symptom Score ≤ 15
• • Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
• Exclusion Criteria:
• Patient will be excluded if they meet any one of the following criteria:
• • Gleason score \>7
• • PSA \>20
• • 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 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
• • WBC less than 3.5/ml
• • Abnormal renal function tests (creatinine \> 1.5)