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

Primary Purpose

Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Dose Rate Brachytherapy
Quality-of-Life Assessment
Questionnaire Administration
Stereotactic Body Radiation Therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

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

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (SBRT)

Arm II (HDR brachytherapy)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Biochemical progression free survival
Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
Incidence of adverse events
Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Will be defined as the percentage of patients who encounter adverse events and calculated to indicate the toxicity level of focal radiation therapy.
Change in quality of life
Will be assessed using Prostate-Quality of Life and Expanded Prostate Cancer Index Composite. The change of the two scores will be assessed via two-sided paired t-test.

Secondary Outcome Measures

Prostate-specific antigen (PSA) response
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.
Clinical progression free survival
Distant metastasis free survival
Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
Development of castration-resistant disease
Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)]
Overall survival
Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

Full Information

First Posted
March 24, 2020
Last Updated
November 4, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04399824
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not open
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (SBRT)
Arm Type
Experimental
Arm Description
Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (HDR brachytherapy)
Arm Type
Experimental
Arm Description
Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Radiation
Intervention Name(s)
High-Dose Rate Brachytherapy
Other Intervention Name(s)
Brachytherapy, High Dose
Intervention Description
Undergo HDR brachytherapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Biochemical progression free survival
Description
Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
Time Frame
At 5 years
Title
Incidence of adverse events
Description
Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Will be defined as the percentage of patients who encounter adverse events and calculated to indicate the toxicity level of focal radiation therapy.
Time Frame
Up to 120 months (10 years)
Title
Change in quality of life
Description
Will be assessed using Prostate-Quality of Life and Expanded Prostate Cancer Index Composite. The change of the two scores will be assessed via two-sided paired t-test.
Time Frame
Baseline up to 120 months
Secondary Outcome Measure Information:
Title
Prostate-specific antigen (PSA) response
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.
Time Frame
At 3, 6, 12, and 24 months
Title
Clinical progression free survival
Time Frame
At 5 years
Title
Distant metastasis free survival
Description
Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
Time Frame
At 5 years
Title
Development of castration-resistant disease
Description
Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)]
Time Frame
Up to 120 months (10 years)
Title
Overall survival
Description
Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
Time Frame
At 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan C Lee
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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