Clinical trial NCT01859689: Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
Official title: A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical PSA control using the Phoenix definition of PSA nadir + 2
timeFrame: 5 years
Secondary outcomes:
measure: Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
timeFrame: 3 months
measure: Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
timeFrame: 6 months
measure: Changes in health related quality of life (HR-QOL) as determined by EPIC scores
timeFrame: Up to 24 months
measure: Changes in HR-QOL as determined by IIEF scores
timeFrame: Up to 24 months
measure: Changes in HR-QOL as determined by IPSS scores
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Mitchell Kamrava
role: PRINCIPAL_INVESTIGATOR
References: