Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer
Withdrawn before enrolling · Not applicable
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04399824
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 0
- Starts
- 2020-04-03
- Expected to finish
- 2020-04-03
- Last updated by the study team
- 2020-11-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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