Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: MR-based image-guided, intensity-modulated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03269422

17-407

Details and patient eligibility

About

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.

Enrollment: 35 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• Additionally, patients will be required to meet the following criteria:

  • Age >18
  • KPS > 80
  • Prostate size < 60cc
  • Presence of a prostatic lesion with maximum dimension of >/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
  • International Prostrate Symptom Score < 15
  • Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria

Exclusion criteria

• Prior androgen deprivation therapy for prostate cancer

• 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 or inability to lie flat for the duration of the study, etc.

• Metallic hip implant, 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 MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.

• Prior history of transurethral resection of the prostate

• Prior history of chronic prostatitis

• 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. 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

MR Image Guided, Intensity-Modulated Radiotherapy

Experimental group

Description:

Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.

Treatment:

Radiation: MR-based image-guided, intensity-modulated radiotherapy