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SBRT in 4 Fractions for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SBRT
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≤ 85years.
  • WHO performance status ≤ 2.
  • PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
  • Histologically proven prostate adenocarcinoma
  • No pathologic lymph nodes on CT/ MRI scan.
  • No distant metastases.
  • No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
  • No malignant tumours in the previous 5 years.
  • IPSS 0-7.
  • Combined HT according to risk factors.
  • Informed consent.

Exclusion Criteria:

  • Prostate size greater than 60cc.
  • Previous TURP less than 6 weeks before radiotherapy.
  • Previous prostate surgery other than TURP.
  • Diabetes *.
  • Use of anticoagulants drugs *.
  • Chronic inflammatory bowel disease *.
  • Previous pelvic irradiation.
  • Inability to obtain written informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SBRT in 4 fraction

    Arm Description

    Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT

    Outcomes

    Primary Outcome Measures

    Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
    Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
    Tumour response to local radiation therapy by assessing freedom from biochemical failure.
    Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2019
    Last Updated
    March 11, 2019
    Sponsor
    Istituto Clinico Humanitas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03873090
    Brief Title
    SBRT in 4 Fractions for Prostate Cancer
    Official Title
    Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 12, 2013 (Actual)
    Primary Completion Date
    May 23, 2018 (Actual)
    Study Completion Date
    May 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istituto Clinico Humanitas

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SBRT in 4 fraction
    Arm Type
    Experimental
    Arm Description
    Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT
    Intervention Type
    Other
    Intervention Name(s)
    SBRT
    Intervention Description
    hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.
    Primary Outcome Measure Information:
    Title
    Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
    Description
    Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
    Time Frame
    up to 5 years
    Title
    Tumour response to local radiation therapy by assessing freedom from biochemical failure.
    Description
    Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
    Time Frame
    up to 5 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≤ 85years. WHO performance status ≤ 2. PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c. Histologically proven prostate adenocarcinoma No pathologic lymph nodes on CT/ MRI scan. No distant metastases. No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT). No malignant tumours in the previous 5 years. IPSS 0-7. Combined HT according to risk factors. Informed consent. Exclusion Criteria: Prostate size greater than 60cc. Previous TURP less than 6 weeks before radiotherapy. Previous prostate surgery other than TURP. Diabetes *. Use of anticoagulants drugs *. Chronic inflammatory bowel disease *. Previous pelvic irradiation. Inability to obtain written informed consent.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    SBRT in 4 Fractions for Prostate Cancer

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