Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
20-000051
- SECONDARY ID:
NCI-2020-01464
- SECONDARY ID:
20-000051
- NCT ID:
NCT04399824
Conditions
- 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
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm I (SBRT) | Experimental | Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity. | |
Arm II (HDR brachytherapy) | Experimental | Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Biochemical progression free survival |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy. |
Secondary Outcome Measures
Measure: | Prostate-specific antigen (PSA) response |
Time Frame: | At 3, 6, 12, and 24 months |
Safety Issue: | |
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. |
Measure: | Clinical progression free survival |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Distant metastasis free survival |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy. |
Measure: | Development of castration-resistant disease |
Time Frame: | Up to 120 months (10 years) |
Safety Issue: | |
Description: | Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)] |
Measure: | Overall survival |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | Jonsson Comprehensive Cancer Center |
Last Updated
November 6, 2020