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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399824
Recruitment Status : Withdrawn (Study did not open)
First Posted : May 22, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Radiation: High-Dose Rate Brachytherapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Radiation Therapy (FRaT) Trial in Patients With Low/Intermediate-Risk Prostate Cancer
Actual Study Start Date : April 3, 2020
Actual Primary Completion Date : April 3, 2020
Actual Study Completion Date : April 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (SBRT)
Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.
 Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy
Experimental: Arm II (HDR brachytherapy)
Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.
 Radiation: High-Dose Rate Brachytherapy
Undergo HDR brachytherapy
Other Name: Brachytherapy, High Dose

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical progression free survival [ Time Frame: At 5 years ]
    Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

  2. Incidence of adverse events [ Time Frame: Up to 120 months (10 years) ]
    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.

  3. Change in quality of life [ Time Frame: Baseline up to 120 months ]
    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 :
  1. Prostate-specific antigen (PSA) response [ Time Frame: At 3, 6, 12, and 24 months ]
    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.

  2. Clinical progression free survival [ Time Frame: At 5 years ]
  3. Distant metastasis free survival [ Time Frame: At 5 years ]
    Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.

  4. Development of castration-resistant disease [ Time Frame: Up to 120 months (10 years) ]
    Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)]

  5. Overall survival [ Time Frame: At 5 years ]
    Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399824


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Alan C Lee UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04399824    
Other Study ID Numbers: 20-000051
NCI-2020-01464 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-000051 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases