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Brachytherapy

HDR vs LDR Brachytherapy for Prostate Cancer (BrachyQOL Trial)

N/A

Waitlist Available

Led By Francois Bachand, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk prostate cancer with one of the following factors: T3a, Gleason Score 8-10, 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

Upper tier intermediate risk with at least 2 of the following factors: Tumor-Nodes-Metastases Tumor stage T2B or greater, Gleason Score 7, PSA > 10, > 50% of the biopsies positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

BrachyQOL Trial Summary

This trial is testing whether a high dose or low dose of radiation is better for treating prostate cancer without surgery. They also want to know if there are any side effects from either dose and if quality of life is affected.

Who is the study for?

This trial is for men with intermediate to high-risk prostate cancer, who have not had surgery. They must have at least two of certain risk factors like a tumor stage T2B or higher, Gleason Score of 7, PSA over 10, or more than half their biopsies positive; or one high-risk factor like T3a stage, Gleason Score 8-10, or PSA over 20.Check my eligibility

What is being tested?

The study compares two types of brachytherapy 'boosts' added to external beam radiotherapy for prostate cancer: High Dose Rate (HDR) and Low Dose Rate (LDR). It aims to see if HDR leads to better survival rates without the disease getting worse and has fewer side effects and improved life quality compared to LDR.See study design

What are the potential side effects?

Potential side effects from both HDR and LDR brachytherapy may include discomfort at the treatment site, urinary issues such as frequency or urgency, bowel changes like diarrhea, erectile dysfunction, and fatigue.

BrachyQOL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer is intermediate risk with at least 2 of these: T2B or higher stage, Gleason Score 7, PSA over 10, more than half of biopsies positive.

BrachyQOL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Quality of Life long term

Other outcome measures

Efficacy: cancer free status

BrachyQOL Trial Design

2Treatment groups

Active Control

Group I: LDR boostActive Control1 Intervention

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

Group II: HDR boostActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,321 Total Patients Enrolled

23 Trials studying Prostate Cancer

5,622 Patients Enrolled for Prostate Cancer

BC Cancer FoundationOTHER

17 Previous Clinical Trials

8,169 Total Patients Enrolled

3 Trials studying Prostate Cancer

508 Patients Enrolled for Prostate Cancer

Francois Bachand, MDPrincipal InvestigatorBritish Columbia Cancer Agency

1 Previous Clinical Trials

25 Total Patients Enrolled

1 Trials studying Prostate Cancer

25 Patients Enrolled for Prostate Cancer

Media Library

HDR (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01936883 — N/A

Prostate Cancer Research Study Groups: LDR boost, HDR boost

Prostate Cancer Clinical Trial 2023: HDR Highlights & Side Effects. Trial Name: NCT01936883 — N/A

HDR (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01936883 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study consider applicants aged 60 or above?

"This clinical trial is recruiting individuals aged 45 and over who are under the age of 80."

Answered by AI

Are there still opportunities for individuals to get involved in this research?

"As per clinicaltrials.gov, this particular medical trial is not recruiting patients at the present moment; it was initially posted on January 1st 2014 with its most recent update occurring in April 12th 2023. However, there are still 1321 other trials that are currently looking for candidates to participate."

Answered by AI

Would I be able to partake in this research program?

"Eligible patients for this clinical trial should have a diagnosis of prostate cancer and be between 45-80 years old. Up to 190 subjects are being sought after."

Answered by AI

Recent research and studies

Radiotherapy and OncologyJournal

Comparison of Three Radiotherapy Modalities on Biochemical Control and Overall Survival for the Treatment of Prostate Cancer: A Systematic Review

Pieters, Bradley R., Djuna Z. de Back, Caro C.E. Koning, and Aeilko H. Zwinderman. 2009. “Comparison of Three Radiotherapy Modalities on Biochemical Control and Overall Survival for the Treatment of Prostate Cancer: A Systematic Review”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2009.08.033.

BrachytherapyJournal

A Phantom Study to Assess Accuracy of Needle Identification in Real-time Planning of Ultrasound-guided High-dose-rate Prostate Implants

Schmid, Matthew, Juanita M. Crook, Deidre Batchelar, Cynthia Araujo, David Petrik, David Kim, and Ross Halperin. 2013. “A Phantom Study to Assess Accuracy of Needle Identification in Real-time Planning of Ultrasound-guided High-dose-rate Prostate Implants”. Brachytherapy. Elsevier BV. doi:10.1016/j.brachy.2012.03.002.

BrachytherapyJournal

Comparison of PSA Relapse-free Survival in Patients Treated with Ultra-high-dose IMRT Versus Combination HDR Brachytherapy and IMRT

Deutsch, Israel, Michael J. Zelefsky, Zhigang Zhang, Qianxing Mo, Marco Zaider, Gil’ad Cohen, Oren Cahlon, and Yoshiya Yamada. 2010. “Comparison of PSA Relapse-free Survival in Patients Treated with Ultra-high-dose IMRT Versus Combination HDR Brachytherapy and IMRT”. Brachytherapy. Elsevier BV. doi:10.1016/j.brachy.2010.02.196.

clinicaltrials.govStudy