Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | March 2012 |
A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
This phase II trial studies how well internal radiation therapy works in treating patients
with low-risk prostate cancer. Internal radiation uses radioactive material placed directly
into or near a tumor to kill tumor cells.
with low-risk prostate cancer. Internal radiation uses radioactive material placed directly
into or near a tumor to kill tumor cells.
PRIMARY OBJECTIVES:
I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using
the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
I. To assess acute and late toxicity outcomes following targeted brachytherapy according to
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using
the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International
Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score
(IPSS) questionnaire.
III. To assess the potential value of multiparametric magnetic resonance imaging, including
dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular
tactographic imaging in predicting the development of equivocal disease (ED) following
radiation treatment.
OUTLINE:
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using
the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
I. To assess acute and late toxicity outcomes following targeted brachytherapy according to
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using
the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International
Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score
(IPSS) questionnaire.
III. To assess the potential value of multiparametric magnetic resonance imaging, including
dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular
tactographic imaging in predicting the development of equivocal disease (ED) following
radiation treatment.
OUTLINE:
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Inclusion Criteria:
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Unilateral prostate cancer as determined by prostate biopsy
- Less than or equal to 3 positive biopsy cores
- No biopsy core >= 50% positive for cancer
- Karnofsky performance status (KPS) >= 70
- At least a 12 core prostate biopsy; if this was not performed then it will be
repeated here at University of California at Los Angeles (UCLA)
- Artemis guided biopsy of any suspicious target lesions as identified on
multiparametric (mp)-magnetic resonance imaging (MRI)
- Clinical stage T1c or T2a
- PSA < 10 ng/ml
- Gleason score 3+3=6
Exclusion Criteria:
- Patients who have previously received radiation therapy to the pelvis
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
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