Clinical Trials /

Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

NCT02339948

Description:

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Completed

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
  • Official Title: A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: 21C-2006-01
  • NCT ID: NCT02339948

Conditions

  • Prostate Adenocarcinoma

Purpose

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.

Detailed Description

      Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason
      score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a
      and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total
      of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive
      1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a
      boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be
      assessed for toxicity at periodic time points following completion of treatment.
    

Trial Arms

NameTypeDescriptionInterventions
SBRT onlyActive ComparatorPatients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy
    IMRT plus SBRT BoostActive ComparatorPatients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Histologically determined adenocarcinoma is required.
      
                -  All other histologies are excluded.
      
                -  Tissue for diagnosis must be obtained by transrectal ultrasound biopsy.
      
                -  Gleason scoring classification of the biopsy specimen is required and must be greater
                   than or equal to 7.
      
                -  2002 AJCC clinical cancer stage as determined by either urologist or radiation
                   oncologist must be T1c - T2b, N0, M0.
      
                -  N0 stage may be assigned following either negative imaging or negative pathologic
                   assessment.
      
                -  Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5.
      
                -  PSA must be less than 20 ng/ml. ,
      
                -  Age ≥ 18,
      
                -  IPSS voiding symptoms score must be less than 18,
      
                -  Study consent form must be signed by the patient.
      
              Exclusion Criteria:
      
                -  Gleason score of 8 - 10,
      
                -  Clinical stage T3 - T4,
      
                -  Age ≤ 18,
      
                -  Any evidence of nodal (N1) or distant (M1) disease,
      
                -  Prostate volume as assessed by TRUS > 60 cc,
      
                -  PSA > 20 ng/ml,
      
                -  IPSS voiding symptoms score > 18,
      
                -  Prior TURP,
      
                -  Prior pelvic radiotherapy or chemotherapy,
      
                -  Prior prostatectomy,
      
                -  Prior cancer other than basal cell or squamous cell skin carcinoma unless free of
                   disease for > 5 years,
      
                -  Current medical or psychiatric illness that may interfere with treatment completion
                   and followup,
      
                -  Hip prosthesis,
      
                -  Unable or unwilling to give informed consent
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:Accepts Healthy Volunteers

      Primary Outcome Measures

      Measure:To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy
      Time Frame:Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years.
      Safety Issue:
      Description:At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:21st Century Oncology

      Trial Keywords

      • Locally confined

      Last Updated

      January 8, 2019