Status:
WITHDRAWN
Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Adenocarcinoma
Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Eligibility:
MALE
18+ years
Phase:
NA
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-r...
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 Prost...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04399824
Start Date
April 3 2020
End Date
April 3 2020
Last Update
November 6 2020
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095