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

Prostate Cancer Clinical Trial

— BrachyQOL  

Official title:

IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01936883
• Other study ID #: H13-02139
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2029

Study information

• Verified date: March 2024
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: December 2029
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• HDR
High dose rate brachytherapy
• LDR
Low dose rate brachytherapy boost

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency Center for the Southern Interior	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	BC Cancer Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Bachand F, Martin AG, Beaulieu L, Harel F, Vigneault E. An eight-year experience of HDR brachytherapy boost for localized prostate cancer: biopsy and PSA outcome. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):679-84. doi: 10.1016/j.ijrobp.2008.05.003. Epub 2008 Oct 27. — View Citation

Deutsch I, Zelefsky MJ, Zhang Z, Mo Q, Zaider M, Cohen G, Cahlon O, Yamada Y. Comparison of PSA relapse-free survival in patients treated with ultra-high-dose IMRT versus combination HDR brachytherapy and IMRT. Brachytherapy. 2010 Oct-Dec;9(4):313-8. doi: 10.1016/j.brachy.2010.02.196. Epub 2010 Aug 4. — View Citation

Morton GC, Loblaw DA, Chung H, Tsang G, Sankreacha R, Deabreu A, Zhang L, Mamedov A, Cheung P, Batchelar D, Danjoux C, Szumacher E. Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1299-305. doi: 10.1016/j.ijrobp.2010.04.046. Epub 2010 Aug 12. — View Citation

Pieters BR, de Back DZ, Koning CC, Zwinderman AH. Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. Radiother Oncol. 2009 Nov;93(2):168-73. doi: 10.1016/j.radonc.2009.08.033. Epub 2009 Sep 11. — View Citation

Schmid M, Crook JM, Batchelar D, Araujo C, Petrik D, Kim D, Halperin R. A phantom study to assess accuracy of needle identification in real-time planning of ultrasound-guided high-dose-rate prostate implants. Brachytherapy. 2013 Jan-Feb;12(1):56-64. doi: 10.1016/j.brachy.2012.03.002. Epub 2012 Apr 17. — View Citation

Stock RG, Stone NN, Cesaretti JA, Rosenstein BS. Biologically effective dose values for prostate brachytherapy: effects on PSA failure and posttreatment biopsy results. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):527-33. doi: 10.1016/j.ijrobp.2005.07.981. Epub 2005 Oct 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy: cancer free status	regular PSA monitoring every 6 months to 3 years and then annually to determine PSA recurrence free survival	10 years
Primary	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.	6 months
Secondary	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	5 years