Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01464 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20-000051 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Study did not open
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Rate Brachytherapy | Radiation | Undergo HDR brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 5 years |
| 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. | Up to 120 months (10 years) |
| 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. | Baseline up to 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3, 6, 12, and 24 months |
| Clinical progression free survival |
Not provided
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:
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
Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan C Lee | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
|
|
| At 5 years |
| Distant metastasis free survival | Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy. | At 5 years |
| Development of castration-resistant disease | Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)] | Up to 120 months (10 years) |
| Overall survival | Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy. | At 5 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided