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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01859689
• Other study ID #: 11-003235
• Secondary ID: NCI-2013-00647
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

Radiation:
• brachytherapy
Undergo image-guided HDR brachytherapy
• image-guided radiation therapy
Undergo image-guided HDR brachytherapy

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical PSA control using the Phoenix definition of PSA nadir + 2		5 years
Secondary	Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0		3 months
Secondary	Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0		6 months
Secondary	Changes in health related quality of life (HR-QOL) as determined by EPIC scores		Up to 24 months
Secondary	Changes in HR-QOL as determined by IIEF scores		Up to 24 months
Secondary	Changes in HR-QOL as determined by IPSS scores		Up to 24 months