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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: HDR; Radiation: LDR

• Registration Number: NCT01936883
• Lead Sponsor: British Columbia Cancer Agency

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-06
• Study Start: 2014-01
• Primary Completion: 2019-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 190

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 6 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HDR boost	HDR	Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.
LDR boost	LDR	After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy

Primary Outcome Measures

Name	Time	Method
Compare Quality of Life between two arms as measured by EPIC questionnaire	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

British Columbia Cancer Agency Center for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada