Clinical Trials /

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

NCT03269422

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
  • Official Title: A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy

Clinical Trial IDs

  • ORG STUDY ID: 17-407
  • NCT ID: NCT03269422

Conditions

  • Prostate Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
MR Image Guided, Intensity-Modulated RadiotherapyExperimentalPatients 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.

    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
    
              -  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)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
    Time Frame:36 months
    Safety Issue:
    Description:Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • 17-407
    • Intermediate Risk Prostate Cancer
    • DIL
    • Dominant Intra-Prostatic Lesion

    Last Updated

    November 14, 2019