Clinical Trials /

Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer

NCT02353819

Description:

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice. - Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint - Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems - Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate - Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy - To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS) - Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation—to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer
  • Official Title: Phase I Clinical Trial of Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets for Patients With High Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: STU 062014-027
  • NCT ID: NCT02353819

Conditions

  • Prostate Cancer

Purpose

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice. - Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint - Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems - Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate - Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy - To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS) - Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation—to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).

Detailed Description

      Patients will be accrued in alternating dose levels. The two distinct areas of dose
      escalations (pelvic lymph node and prostate lesion) will take place one at a time. Minimum
      waiting periods will be assigned between each dose cohort to observe toxicity. The phase I
      portion of the study will be completed when dose limiting toxicity is reached or when a
      sufficiently high dose level (i.e.,5.5 Gy per fraction to a total 27.5 Gy for pelvic lymph
      node region and 11Gy per fraction to a total of 55Gy to the prostate lesion), is attained to
      consider the therapy likely to be efficacious. All patients will be treated with a total of
      24 months of androgen suppression therapy (ADT). Radiation therapy will start 8-12 weeks
      after initiation of ADT.

      No. Patients for each cohort: 7-15 Cohort 1: 9.5 Gy per fraction to prostate/SV, 10 Gy per
      fraction to prostate lesion, 4.5Gy per fraction to pelvic lymph node region for 5 fractions
      for a total of 47.5 / 50 / 22.5 Gy to Prostate+SV /Prostate lesions/Nodes Cohort 2: 9.5 Gy
      per fraction to prostate/SV, 10 Gy per fraction to prostate lesion, 5Gy per fraction to
      pelvic lymph node region for 5 fractions for a total of 47.5 / 50 / 25 Gy to Prostate+SV
      /Prostate lesions/Nodes Cohort 3: 9.5 Gy per fraction to prostate/SV, 10.5 Gy per fraction to
      prostate lesion, 5Gy per fraction to pelvic lymph node region for 5 fractions for a total of
      47.5 / 52.5 / 25 Gy to Prostate+SV /Prostate lesions/Nodes Cohort 4: 9.5 Gy per fraction to
      prostate/SV, 10.5 Gy per fraction to prostate lesion, 5.5 Gy per fraction to pelvic lymph
      node region for 5 fractions for a total of 47.5 / 52.5 / 27.5 Gy to Prostate+SV /Prostate
      lesions/Nodes Cohort 5: 9.5 Gy per fraction to prostate/SV, 11 Gy per fraction to prostate
      lesion, 5.5 Gy per fraction to pelvic lymph node region for 5 fractions for a total of 47.5 /
      55 / 27.5 Gy to Prostate+SV /Prostate lesions/Nodes
    

Trial Arms

NameTypeDescriptionInterventions
Stereotactic Ablative RadiotherapyExperimentalStereotactic Ablative Radiotherapy (SABR)

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Signed study specific informed consent form.
    
              -  PSA ≥20
    
              -  OR Gleason score ≥ 8
    
              -  OR Appropriate staging studies identifying as AJCC stage cT3+
    
                   -  (MR stage T3a without other high risk factors permitted at investigator
                      discretion).
    
              -  No direct evidence of regional or distant metastases after appropriate staging studies
                 as indicated clinically.
    
              -  Clinically negative lymph nodes as established by imaging (abdominal and pelvic CT or
                 abdominal and pelvic MRI), nodal sampling, or dissection within 90 days prior to
                 registration.
    
              -  Patients with lymph nodes equivocal or questionable by imaging are eligible if the
                 nodes are < 2.0 cm in the short axis.
    
              -  No distant metastases (M0) on bone scan within 90 days prior to registration.
    
              -  Histologic confirmation of cancer by biopsy
    
              -  Adenocarcinoma of the prostate
    
              -  Age ≥18
    
              -  Zubrod Performance Status 0-2
    
              -  AUA score must be ≤20 (alpha blockers allowed)
    
              -  CT or Ultrasound-based volume estimation of prostate gland ≤80 grams (repeat
                 ultrasound measurement after hormone downsizing allowed)
    
              -  Agreement to use effective contraceptive methods such as condom/diaphragm and
                 spermicidal foam, intrauterine device, or prescription birth control pills.
    
              -  Equivocal bone scan findings are allowed if plain films are negative for metastasis.
    
              -  Deemed eligible for Complete Androgen Blockade (CAB) hormone therapy by treating
                 physician, including baseline liver function evaluation. For patients not eligible for
                 anti-testosterone therapy, hormone therapy with LHRH agonist alone will be permitted
                 on case by case basis by study P.I.
    
              -  Use of previous hormonal therapy for up to 9 months is allowed for the treatment of
                 prostate cancer as well as for prostate volume reduction.
    
              -  MRI Pelvis/Prostate feasible for staging and planning
    
              -  Clinically eligible for rectal spacer insertion (e.g. Duraseal, SpaceOAR, or
                 equivalent product) per physician evaluation
    
            Exclusion Criteria:
    
              -  Positive lymph nodes or metastatic disease from prostate cancer by imaging studies (CT
                 or MRI), unless biopsy proven to be negative.
    
              -  Evidence of metastatic disease by imaging study
    
              -  Prior invasive malignancy unless disease free for a minimum of 3 years (oral cavity,
                 or non-melanomatous skin cancer are all permissible)
    
              -  Previous pelvic radiotherapy
    
              -  Previous surgery or chemotherapy for prostate cancer
    
              -  Previous transuretheral resection of the prostate (TURP) or cryotherapy to the
                 prostate
    
              -  Previous androgen depravation therapy given for more than 9 months prior to therapy
    
              -  Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally
                 fractionated radiotherapy, and chemotherapy) while on this protocol.
    
              -  History of Crohn's Disease or Ulcerative Colitis.
    
              -  Not actively on immunosuppressive medications.
    
              -  Previous significant obstructive symptoms; AUA score must be ≤20 (alpha blockers
                 allowed)
    
              -  Significant psychiatric illness
    
              -  Men of reproductive potential may not participate unless they agree to use an
                 effective contraceptive method.
    
              -  Ultrasound or CT estimate of prostate volume > 80 grams (after hormone downsizing
                 allowed).
    
              -  Severe, active co-morbidity
    
              -  No nodal disease
    
              -  No known allergies to spacer material: Polyethylene glycol (PEG) hydrogel
          
    Maximum Eligible Age:99 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:maximum tolerated dose (MTD)
    Time Frame:90 days
    Safety Issue:
    Description:Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal PTV using 90 day acute toxicity endpoint

    Secondary Outcome Measures

    Measure:Adverse events
    Time Frame:90 days
    Safety Issue:
    Description:Determine the safety of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate/SV PTV
    Measure:PSA
    Time Frame:5 years
    Safety Issue:
    Description:To follow tumor response to treatment
    Measure:Progression-free survival
    Time Frame:5 years
    Safety Issue:
    Description:To follow tumor related outcomes (progression-free survival (PFS), distant metastasis (DM) free survival)
    Measure:Overall survival
    Time Frame:5 years
    Safety Issue:
    Description:To follow tumor related outcomes , overall survival (OS)
    Measure:Health-related quality of life
    Time Frame:5 years
    Safety Issue:
    Description:Health-related quality of life (HRQOL) will be measured as part of current clinical practice

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Texas Southwestern Medical Center

    Last Updated

    March 14, 2019