Clinical Trials /

Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer

NCT04399824

Description:

This phase II trial studies how well focal radiation therapy with stereotactic body radiation therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or surrounding normal organs and ultimately reduce side effects while maintaining disease control.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Withdrawn

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT04399824

Trial Eligibility

Document

Title

  • Brief Title: Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer
  • Official Title: Focal Radiation Therapy (FRaT) Trial in Patients With Low/Intermediate-Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 20-000051
  • SECONDARY ID: NCI-2020-01464
  • SECONDARY ID: 20-000051
  • NCT ID: NCT04399824

Conditions

  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
  • Stage II Prostate Cancer AJCC v8
  • Stage IIA Prostate Cancer AJCC v8
  • Stage IIB Prostate Cancer AJCC v8
  • Stage IIC Prostate Cancer AJCC v8

Purpose

This phase II trial studies how well focal radiation therapy with stereotactic body radiation therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or surrounding normal organs and ultimately reduce side effects while maintaining disease control.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Evaluate biochemical progression free survival (bPFS) using the Phoenix definition.

      II. Changes in quality of life. IIa. Prostate-Quality of Life (PR-QOL). IIb. Expanded
      Prostate Cancer Index Composite (EPIC).

      SECONDARY OBJECTIVES:

      I. Prostate-specific antigen (PSA) response at 3, 6, 12, and 24 months. II. Clinical
      progression free survival. IIa. Including phoenix definition, local progression by Response
      Evaluation Criteria in Solid Tumors (RECIST), regional progression, distant metastasis, or
      death.

      III. Distant metastasis free survival. IV. Development of castration-resistant disease. V.
      Overall survival.

      OUTLINE: Patients are assigned to 1 of 2 arms.

      ARM I: Patients undergo SBRT in 5 fractions over 14 days in the absence of disease
      progression or unacceptable toxicity.

      ARM II: Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in
      the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 6 weeks, every 3 months for
      up to 24 months, every 6 months for up to 60 months, and then every 8-12 months until 120
      months.

Trial Arms

NameTypeDescriptionInterventions
Arm I (SBRT)ExperimentalPatients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.
    Arm II (HDR brachytherapy)ExperimentalPatients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.

      Eligibility Criteria

              Inclusion Criteria:

          -  Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to
             registration via systematic biopsy and with the following low/intermediate-risk
             features:

               -  cT1c - T2b

               -  PSA =< 15

               -  < 50% cores positive

               -  Gleason score (GS) =< 7 (3+4 and 4+3 included)

          -  Multiparametric magnetic resonance imaging (MRI) (mp-MRI) confirmed lesion(s) with
             only one lobe involvement of the prostate

          -  Unilateral disease on systematic biopsy

          -  No distant or locally advanced disease on standard staging exams as indicated

               -  Bone scan and abdominopelvic computed tomography (CT)/MRI OR

               -  Prostate specific membrane antigen (PSMA) positron emission tomography (PET)

          -  Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days
             prior to enrollment

        Exclusion Criteria:

          -  Gleason score >= 8

          -  Gross extracapsular extension

          -  Seminal vesicle invasion

          -  Radiographic nodal or distant metastatic disease

          -  Androgen deprivation therapy within 90 days of enrollment

          -  Lesion(s) comprising > 40% of total prostate volume

          -  Lesion < 0.5 cm from urethra

          -  Prior radical prostatectomy

          -  Prior radiotherapy to the pelvis
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Biochemical progression free survival
      Time Frame:At 5 years
      Safety Issue:
      Description:Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

      Secondary Outcome Measures

      Measure:Prostate-specific antigen (PSA) response
      Time Frame:At 3, 6, 12, and 24 months
      Safety Issue:
      Description:PSA response of each patient at 3, 6, 12, and 24 months will be collected and the PSA changes from baseline PSA to each time point will be evaluated via two-sided paired t-test.
      Measure:Clinical progression free survival
      Time Frame:At 5 years
      Safety Issue:
      Description:
      Measure:Distant metastasis free survival
      Time Frame:At 5 years
      Safety Issue:
      Description:Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
      Measure:Development of castration-resistant disease
      Time Frame:Up to 120 months (10 years)
      Safety Issue:
      Description:Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)]
      Measure:Overall survival
      Time Frame:At 5 years
      Safety Issue:
      Description:Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Withdrawn
      Lead Sponsor:Jonsson Comprehensive Cancer Center

      Last Updated

      November 6, 2020