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Brachytherapy

HDR vs. LDR Brachytherapy for Prostate Cancer

Q: In order to participate in this trial, is it a requirement to be below a certain age limit?

The age restrictions for this clinical trial are between 40 to 80 years old.

Q: For which patients is this research project recruiting?

This clinical trial is looking for 60 participants who have <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> and are between the ages of 40 and 80. Participants must also meet the following criteria: Clinical stage T1c-T2b, PSA &#x3C; 20, Gleason &#x3C; 8, ECOG 0-1, Low tier intermediate-risk prostate cancer is defined by;, o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA &#x3C; 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml), clinical stage T1c-T2a, PSA &#x3C; 10, Gleason

Q: Are new participants still being accepted into this trial program?

That is correct, the information available on clinicaltrials.gov affirms that this clinical trial is recruiting patients. This specific trial was originally posted on 2016-05-01, and was updated on 2022-03-03. The trial is looking for 60 patients from 1 location.

Q: How many test subjects are needed for this clinical trial?

Yes, the information on clinicaltrials.gov says that this trial is actively looking for candidates. The trial was first posted on 2016-05-01 and was most recently updated on 2022-03-03. The clinical trial is searching for 60 participants between 1 sites.

Q: What are some dangers associated with High Dose Rate prostate brachytherapy?

Because this is a Phase 3 trial, there is some data supporting efficacy and multiple rounds of data supporting safety, so our team at Power estimates the safety of High Dose Rate <a href="https://www.withpower.com/clinical-trials/prostate">prostate</a> brachytherapy to be a 3.

Phase 3

Waitlist Available

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

ECOG 0-1

Clinical stage T1c-T2b, PSA < 20, Gleason < 8

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-10 years

Awards & highlights

Study Summary

This trial will offer men with intermediate risk prostate cancer the opportunity to be randomized between low dose rate brachytherapy and high dose rate brachytherapy. Men will also be offered the opportunity to test the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.

Who is the study for?

Men with intermediate risk prostate cancer who haven't had pelvic radiation, prostate surgery, chemotherapy for prostate cancer, or certain other prostate treatments. They should have a clinical stage T1c-T2b, PSA < 20 ng/ml, Gleason score < 8, and be in good physical condition (ECOG 0-1). Their tumor characteristics must meet specific criteria and they can't be eligible for just monitoring the cancer without treatment.Check my eligibility

What is being tested?

The trial is comparing two types of internal radiation therapy: Low Dose Rate (LDR) brachytherapy involving permanent radioactive seeds and High Dose Rate (HDR) temporary brachytherapy. Participants will be randomly assigned to one of these treatments to see which is more effective at treating intermediate risk prostate cancer.See study design

What are the potential side effects?

Possible side effects from both LDR and HDR brachytherapy may include discomfort or pain during the procedure, urinary issues like frequency or urgency, bowel changes such as diarrhea or rectal bleeding, erectile dysfunction, and fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My prostate cancer is in an early stage, with low PSA and Gleason scores.

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My prostate cancer is early stage, with specific PSA and Gleason scores.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-10 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

The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.

Secondary outcome measures

Acute and long term toxicity

Biochemical Outcome

Cell cycle progression score

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High dose rate brachytherapyExperimental Treatment1 Intervention

Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.

Group II: Low dose rate brachytherapyActive Control1 Intervention

Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,451 Total Patients Enrolled

23 Trials studying Prostate Cancer

5,752 Patients Enrolled for Prostate Cancer

Ross Halperin, MDStudy DirectorBritish Columbia Cancer Agency Program Director

1 Previous Clinical Trials

140 Total Patients Enrolled

1 Trials studying Prostate Cancer

140 Patients Enrolled for Prostate Cancer

Media Library

High Dose Rate Prostate Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02692105 — Phase 3

Prostate Cancer Research Study Groups: Low dose rate brachytherapy, High dose rate brachytherapy

Prostate Cancer Clinical Trial 2023: High Dose Rate Prostate Brachytherapy Highlights & Side Effects. Trial Name: NCT02692105 — Phase 3

High Dose Rate Prostate Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02692105 — Phase 3

Frequently Asked Questions

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

In order to participate in this trial, is it a requirement to be below a certain age limit?

"The age restrictions for this clinical trial are between 40 to 80 years old."

Answered by AI

For which patients is this research project recruiting?

"This clinical trial is looking for 60 participants who have prostate cancer and are between the ages of 40 and 80. Participants must also meet the following criteria: Clinical stage T1c-T2b, PSA < 20, Gleason < 8, ECOG 0-1, Low tier intermediate-risk prostate cancer is defined by;, o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml), clinical stage T1c-T2a, PSA < 10, Gleason"

Answered by AI

Are new participants still being accepted into this trial program?

"That is correct, the information available on clinicaltrials.gov affirms that this clinical trial is recruiting patients. This specific trial was originally posted on 2016-05-01, and was updated on 2022-03-03. The trial is looking for 60 patients from 1 location."

Answered by AI

How many test subjects are needed for this clinical trial?

"Yes, the information on clinicaltrials.gov says that this trial is actively looking for candidates. The trial was first posted on 2016-05-01 and was most recently updated on 2022-03-03. The clinical trial is searching for 60 participants between 1 sites."

Answered by AI

What are some dangers associated with High Dose Rate prostate brachytherapy?

"Because this is a Phase 3 trial, there is some data supporting efficacy and multiple rounds of data supporting safety, so our team at Power estimates the safety of High Dose Rate prostate brachytherapy to be a 3."

Answered by AI

Recent research and studies

BrachytherapyJournal

Ultrasound-planned High-dose-rate Prostate Brachytherapy: Dose Painting to the Dominant Intraprostatic Lesion

Crook, Juanita, Ana Ots, Miren Gaztañaga, Matt Schmid, Cynthia Araujo, Michelle Hilts, Deidre Batchelar, Brent Parker, François Bachand, and Marie-Pierre Milette. 2014. “Ultrasound-planned High-dose-rate Prostate Brachytherapy: Dose Painting to the Dominant Intraprostatic Lesion”. Brachytherapy. Elsevier BV. doi:10.1016/j.brachy.2014.05.006.

BrachytherapyJournal

Validation Study of Ultrasound-based High-dose-rate Prostate Brachytherapy Planning Compared with Ct-based Planning

Batchelar, Deidre, Miren Gaztañaga, Matt Schmid, Cynthia Araujo, François Bachand, and Juanita Crook. 2014. “Validation Study of Ultrasound-based High-dose-rate Prostate Brachytherapy Planning Compared with Ct-based Planning”. Brachytherapy. Elsevier BV. doi:10.1016/j.brachy.2013.08.004.

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.

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