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

Jonsson Comprehensive Cancer Center

Status and phase: Withdrawn; Phase 2

Conditions: Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Recurrent Prostate Cancer; Stage IIB Prostate Cancer

Treatments: Other: laboratory biomarker analysis; Radiation: image-guided radiation therapy; Radiation: brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01859689

11-003235

NCI-2013-00647 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Treatment (image-guided HDR brachytherapy)

Experimental group

Description:

Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.

Treatment:

Radiation: brachytherapy

Other: laboratory biomarker analysis

Radiation: image-guided radiation therapy