Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer

Phase 2

Withdrawn

• Conditions: Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Recurrent Prostate Cancer; Stage IIB Prostate Cancer
• Interventions: Radiation: brachytherapy; Radiation: image-guided radiation therapy; Other: laboratory biomarker analysis

• Registration Number: NCT01859689
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (image-guided HDR brachytherapy)	brachytherapy	Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Treatment (image-guided HDR brachytherapy)	image-guided radiation therapy	Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Treatment (image-guided HDR brachytherapy)	laboratory biomarker analysis	Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.

Primary Outcome Measures

Name	Time	Method
Biochemical PSA control using the Phoenix definition of PSA nadir + 2	5 years

Secondary Outcome Measures

Name	Time	Method
Changes in HR-QOL as determined by IPSS scores	Up to 24 months
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0	3 months
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0	6 months
Changes in health related quality of life (HR-QOL) as determined by EPIC scores	Up to 24 months
Changes in HR-QOL as determined by IIEF scores	Up to 24 months