Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy

N/AActive Not RecruitingNCT01936883

British Columbia Cancer Agency195 enrolled

Overview

Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.

Men with intermediate or high risk prostate cancer who are technically suitable for prostate brachytherapy based on prostate size and voiding function and who are interested in this modality of treatment will be approached for randomization between either high dose rate (single 15 Gray) or low dose rate permanent seed implant (110 Gray) brachytherapy. Baseline International Prostate Symptom score, Quality of Life Assessment and International Index of Erectile Function will be recorded and then every 3 months for the first year and every 6 months to 3 years. Androgen deprivation treatment is allowed for 6 or 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

195

Conditions

Prostate Cancer

Interventions

HDRRADIATION

High dose rate brachytherapy

LDRRADIATION

Low dose rate brachytherapy boost

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Upper tier intermediate risk with at least 2 of the following factors 1. Tumor-Nodes-Metastases Tumor stage T2B or greater 2. Gleason Score 7 3. PSA \> 10 4. \> 50% of the biopsies positive * OR High risk prostate cancer with one of the following factors 1. T3a 2. Gleason Score8-10 3. PSA \>20 * Positive prostate biopsy within 12 months (reviewed centrally) * International Prostate Symptom Score \< 16 * Prostate volume \< 60 cc * Negative staging CT and Bone scan within 3 months prior to registration * History and physical examination within 90 days prior to registration * European Cooperative Oncology Group performance status 0-1 prior to registration * Age \>45 * Patient suitable for procedure under anesthesia Exclusion Criteria: * Prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration * Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer * Previous pelvic irradiation or prostate brachytherapy

Locations (1)

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, Canada

Outcomes

Primary Outcomes

Compare Quality of Life between two arms as measured by EPIC questionnaire

Quality of life will be measured through validated instruments including International Prostate Symptom Score (IPSS), the International Index of Erectile Function ((IEF), and the urinary, bowel and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). IPSS has 7 questions related to voiding symptoms, each scored 0-5, with a higher score indicating worse symptoms. IIEF has 5 questions, each scored 0-5 with a higher score indicating better function. EPIC has several questions for each domain with an overall higher score associated with better QoL in that domain.

Time frame: 6 months

Secondary Outcomes

Quality of Life long term

Quality of Life will be assessed to 5 years using the validated instruments International Prostate Symptom Score, International Index Erectile Function and EPIC

Time frame: 5 years

Data from ClinicalTrials.gov

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