Clinical Trials /

Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

NCT03541850

Description:

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03541850

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
  • Official Title: Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: 17-001064
  • SECONDARY ID: NCI-2017-02032
  • SECONDARY ID: 17-001064
  • NCT ID: NCT03541850

Conditions

  • PSA Level Greater Than 0.03
  • PSA Progression
  • Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7
  • Stage II Prostate Adenocarcinoma AJCC v7
  • Stage III Prostate Adenocarcinoma AJCC v7

Interventions

DrugSynonymsArms
Antiandrogen TherapyADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation TherapyTreatment (SBRT, ADT)

Purpose

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a
      dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates
      in patients who received conventionally fractionated postoperative radiotherapy.

      II. To determine the toxicity of postoperative SBRT at a dose of 34 Gy in five fractions,
      both via physician-scored and patient-reported metrics.

      SECONDARY OBJECTIVES:

      I. To determine the proportion of SBRT fractions for which on-line adaptive radiotherapy is
      required due to changes in organ-at-risk anatomy, in the subset of patients treated with
      magnetic resonance imaging (MRI)-guided radiotherapy.

      II. To gather biomarkers that may elucidate predictors of increased efficacy or increased
      toxicity.

      TERTIARY OBJECTIVES:

      I. To compare toxicity profiles (both physician-scored and patient-reported) between patients
      treated utilizing a linear accelerator versus a tri-60Co teletherapy platform.

      OUTLINE:

      Patients undergo SBRT every other day (QOD) for 14 days. Patients may also receive androgen
      deprivation therapy (ADT) comprised of a luteinizing hormone-releasing hormone agonist or a
      gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the
      discretion of the treating physician.

      After completion of study treatment, patients are followed up at 1 month, every 3 months for
      1 year, every 6 months for 4 years, and then annually thereafter.

Trial Arms

NameTypeDescriptionInterventions
Treatment (SBRT, ADT)ExperimentalPatients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.
  • Antiandrogen Therapy

Eligibility Criteria

        Inclusion Criteria:

          -  History of histologically confirmed, clinical localized adenocarcinoma of the prostate
             treated with radical prostatectomy with definitive intent

          -  Presence of adverse pathologic features at the time of prostatectomy (positive
             surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10
             disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising
             prostate-specific antigen on at least two consecutive draws, with the magnitude of
             prostate-specific antigen exceeding 0.03 ng/mL

          -  Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to
             enrollment (note: [a] if patient has medical contraindication to MRI, an exemption
             will be granted and enrollment can proceed [b] for patients with PSA < 1.0 ng/mL, the
             treatment planning CT can substitute for a diagnostic CT scan)

          -  Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain
             x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g.,
             18NaF positron emission tomography [PET]/CT) is strongly recommended

          -  Karnofsky performance score (KPS) >= 70

          -  Ability to understand, and willingness to sign, the written informed consent

        Exclusion Criteria:

          -  Patients with any evidence of distant metastases

          -  Patients with pathologically-confirmed N1 prostate cancer

          -  Patients with neuroendocrine or small cell carcinoma of the prostate

          -  Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy
             of the prostate

          -  Prior pelvic radiotherapy

          -  History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Biochemical recurrence-free survival (BCRFS)
Time Frame:Up to 5 years
Safety Issue:
Description:Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.2 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BCRFS time will be calculated with 95% confidence interval. Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.

Secondary Outcome Measures

Measure:Proportion of stereotactic body radiation therapy (SBRT) fractions for which on-line adaptive radiotherapy was utilized in the subset of patient treated with magnetic resonance imaging (MRI)-guided radiotherapy
Time Frame:Up to 5 years
Safety Issue:
Description:Point estimate and the corresponding 95% confidence interval will be calculated for the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with MRI-guided radiotherapy.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jonsson Comprehensive Cancer Center

Last Updated

December 8, 2020