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Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring High Risk Prostate Cancer, prostate, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers
  • Histologically proven prostate adenocarcinoma.
  • Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm.
  • PSA ≤ 50 ng/ml, obtained within 3 months
  • Prostate volume: ≤60 cc.
  • IPSS score ≤15.
  • No previous radiotherapy to the prostate or lower pelvis.
  • Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
  • No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
  • No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
  • Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willing to fill out quality of life questionnaires.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stereotactic Body Radiation Therapy, followed by Prostatectomy

    Arm Description

    Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.

    Outcomes

    Primary Outcome Measures

    Measure of PSA (Prostate Specific Antigen)
    Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
    Number of symptomatic adverse anastomotic events
    Number of symptomatic anastomotic events related to pre-operative SBRT.

    Secondary Outcome Measures

    Mean Catheterization Time
    Average time of catheterization following prostatectomy
    Mean Hospital Stay
    Average time of hospitalization after prostatectomy
    Quality of Life assessment
    Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.

    Full Information

    First Posted
    November 19, 2018
    Last Updated
    May 22, 2020
    Sponsor
    H. Lee Moffitt Cancer Center and Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03748719
    Brief Title
    Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
    Official Title
    A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No accrual interest
    Study Start Date
    November 19, 2018 (Actual)
    Primary Completion Date
    October 15, 2019 (Actual)
    Study Completion Date
    December 4, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    H. Lee Moffitt Cancer Center and Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days. The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    High Risk Prostate Cancer, prostate, radiation therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stereotactic Body Radiation Therapy, followed by Prostatectomy
    Arm Type
    Experimental
    Arm Description
    Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Stereotactic Body Radiation Therapy (SBRT)
    Intervention Description
    SBRT treatment
    Primary Outcome Measure Information:
    Title
    Measure of PSA (Prostate Specific Antigen)
    Description
    Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
    Time Frame
    Up to 12 months
    Title
    Number of symptomatic adverse anastomotic events
    Description
    Number of symptomatic anastomotic events related to pre-operative SBRT.
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    Mean Catheterization Time
    Description
    Average time of catheterization following prostatectomy
    Time Frame
    Up to 4 weeks post surgery
    Title
    Mean Hospital Stay
    Description
    Average time of hospitalization after prostatectomy
    Time Frame
    Up to 2 week post surgery
    Title
    Quality of Life assessment
    Description
    Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.
    Time Frame
    Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Histologically proven prostate adenocarcinoma. Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm. PSA ≤ 50 ng/ml, obtained within 3 months Prostate volume: ≤60 cc. IPSS score ≤15. No previous radiotherapy to the prostate or lower pelvis. Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op. No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted). No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years. No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy. Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2). Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Ability to understand and the willingness to sign a written informed consent document. Willing to fill out quality of life questionnaires.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Johnstone, MD
    Organizational Affiliation
    H. Lee Moffitt Cancer Center and Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://moffitt.org/clinical-trials-research/clinical-trials/
    Description
    Moffitt Cancer Center Clinical Trials Website

    Learn more about this trial

    Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

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