Clinical Trials /

Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer

NCT04253483

Description:

This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer
  • Official Title: A Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 081805
  • SECONDARY ID: NCI-2020-00236
  • SECONDARY ID: Pro2018002793
  • SECONDARY ID: 081805
  • SECONDARY ID: P30CA072720
  • NCT ID: NCT04253483

Conditions

  • Stage I Prostate 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 compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.

Detailed Description

      PRIMARY OBJECTIVE:

      I. To assess feasibility of a pilot randomized trial evaluating stereotactic ablative
      radiotherapy (SABR) and high-dose rate brachytherapy for localized prostate cancer.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients undergo high-dose rate brachytherapy (HDR).

      ARM II: Patients undergo SABR every other day for 5 treatments.

      After completion of study treatment, patients are followed up periodically.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (HDR)ExperimentalPatients undergo HDR.
    Arm II (SABR)ExperimentalPatients undergo SABR every other day for 5 treatments.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9
                   months. Patients on active surveillance with evidence of disease progression are
                   eligible to the protocol as long as they meet the eligibility criteria and have a
                   recent prostate biopsy (within 9 months)
      
                -  Low-risk and intermediate-risk patients are eligible according to the following
                   guidelines:
      
                     -  Low and intermediate-risk disease defined as:
      
                          -  Clinical stage T1-T2 and Gleason =< 7 and prostate specific antigen (PSA) <
                             15 ng/ml
      
                -  Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging
                   (MRI) and bone scan are optional and are left at the discretion of the treating
                   physician
      
                -  Prostate MRI is recommended by not mandatory
      
                -  No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of
                   2 weeks is required prior to randomization
      
                -  Eastern Cooperative Oncology Group status 0-1
      
                -  Judged to be medically fit for brachytherapy by a radiation oncologist
      
                -  Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not
                   permitted
      
                -  Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc
      
                -  International Prognostic Scoring System (IPSS) =< 20 (alpha blockers allowed)
      
                -  Patients must sign a study specific informed consent form prior to study entry
      
                -  Patients must by accessible for treatment and follow-up. Patients registered on this
                   trial must be treated and followed at the participating center. Investigators must
                   assure themselves that patients enrolled in this trial will be available for complete
                   documentation of the treatment, adverse events, and follow up
      
                -  Protocol treatment is to begin within 4 weeks of patient randomization
      
              Exclusion Criteria:
      
                -  Patients with a history of other malignancies, except: adequately treated non-melanoma
                   skin cancer, or other solid tumors curatively treated with no evidence of disease for
                   >= 5 years
      
                -  Prior or current bleeding diathesis
      
                -  Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior
                   chemotherapy for prostate cancer, prior transurethral resection of the prostate
                   (TURP), prior cryosurgery of the prostate
      
                -  Stage T3b and evidence of nodal or distant metastatic disease on diagnostic CT, MRI or
                   bone scan
      
                -  Subjects who have plans to receive other concomitant or post treatment adjuvant
                   antineoplastic therapy while on this protocol including surgery, cryotherapy,
                   conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as
                   part of the treatment of prostate cancer
      
                -  Severe, active co-morbidity, defined as follows:
      
                     -  Unstable angina and/or congestive heart failure requiring hospitalization within
                        the last 6 months
      
                     -  Transmural myocardial infarction within the last 6 months
      
                     -  Acute bacterial for fungal infection requiring intravenous antibiotics at the
                        time of registration
      
                     -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                        requiring hospitalization or precluding study therapy within 30 days before
                        registration
      
                     -  Hepatic insufficiency resulting in clinical jaundice and/or coagulations defects;
                        note, however, that laboratory tests for liver function and coagulation
                        parameters are not required for entry into this protocol
      
                     -  Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
                        Control and Prevention (CDC) definition; note, however, that human
                        immunodeficiency virus (HIV) testing is not required for entry into this
                        protocol. The need to exclude patients with AIDS from this protocol is necessary
                        because the treatments involved in this protocol may be significantly
                        immunosuppressive. Protocol-specific requirements may also exclude
                        immumo-compromised patients
      
                     -  Patients with history of inflammatory colitis (including Crohn's disease and
                        ulcerative colitis) or collagen vascular diseases including rheumatoid arthritis
                        and lupus are not eligible
      
                -  Subjects who have a history of significant psychiatric illness
      
                -  Men of reproductive potential who do not agree that they or their partner will use an
                   effective contraceptive method such as condom/diaphragm and spermicidal foam,
                   intrauterine device (IUD), or prescription birth control pills
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Feasibility of comparing stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy (HDRB)
      Time Frame:36 months
      Safety Issue:
      Description:Feasibility is defined as success in enrolling patients, performing the procedures, reporting adverse effects, collecting and managing data across several institutions and patient compliance in completing health-related quality of life questionnaires.

      Secondary Outcome Measures

      Measure:Changes in patient reported Health-Related Quality of life (HRQoL)
      Time Frame:Baseline up to 36 months
      Safety Issue:
      Description:Will be assessed by the Expanded Prostate Cancer Index Composite (EPIC)-26 short form at baseline, 1,3,6,9,12,18,24 and 36 months. The response to each EPIC item is standardized to a 0 to 100 scale, with higher scores representing better quality of life. Each domain is then scored by adding the score of each item within the group divided by the total number of items. Since androgen-deprivation therapy is not permitted in our study, the hormonal score will not be reported. HRQoL scores in the bowel, sexual, urinary incontinence and irritative domains will be evaluated.
      Measure:Changes in patient-reported urinary toxicity
      Time Frame:Baseline up to 36 months
      Safety Issue:
      Description:Will be assessed by American Urology Association Symptom Score questionnaires (AUA) at baseline, 1,3,6,9,12,18,24 and 36 months. The AUA evaluates urinary function, 7 questions, total score is 35. The higher the score, the higher rate of urinary toxicity.
      Measure:Changes in patient-reported sexual toxicity
      Time Frame:Baseline up to 36 months
      Safety Issue:
      Description:Will be assessed by Sexual Health Inventory for Men (SHIM) questionnaires at baseline, 1,3,6,9,12,18,24 and 36 months. The SHIM, score 1-25 lower score reflecting severe erectile dysfunction.
      Measure:Incidence of adverse events
      Time Frame:Baseline up to 36 months
      Safety Issue:
      Description:Physician-reported adverse events using the Common Terminology Criteria for Adverse Events version 4.0 will be reported at baseline, 1,3,6,9,12,18,24 and 36 months at each patient visit.

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Rutgers, The State University of New Jersey

      Last Updated

      February 6, 2020