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Brachytherapy

HDR vs LDR Brachytherapy for Prostate Cancer (LDR/HDRmono Trial)

N/A

Recruiting

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

Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.

Extensive favorable-risk disease is defined as: clinical stage T1c-T2a PSA < 10 Gleason 6 ≥ 50% of biopsy cores containing cancer PSA density > 0.2 ng/cc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-10 years

Awards & highlights

LDR/HDRmono Trial Summary

This trial is comparing two types of prostate cancer treatments to see which is more effective.

Who is the study for?

Men with favorable to intermediate-risk prostate cancer, who have a life expectancy of at least 10 years and are not candidates for active surveillance. They should have no prior radical prostate surgeries or treatments like TURP, cryosurgery, pelvic radiation, or chemotherapy for prostate cancer. Their PSA levels and Gleason scores must meet specific criteria.Check my eligibility

What is being tested?

This trial compares two types of internal radiation therapy for treating prostate cancer: high dose rate (HDR) vs. low dose rate (LDR) brachytherapy. It's designed to see which method is more effective in patients with certain risk levels of prostate cancer.See study design

What are the potential side effects?

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

LDR/HDRmono Trial Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is at an early or intermediate stage, and I am expected to live 10 more years.

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My prostate cancer is at an early stage, with specific test results.

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My prostate cancer is at an early stage, with low PSA and Gleason scores, and I'm mostly active.

LDR/HDRmono Trial 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

LDR/HDRmono 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 anesthesia, 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 anesthesia 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

90,371 Total Patients Enrolled

23 Trials studying Prostate Cancer

5,672 Patients Enrolled for Prostate Cancer

BC Cancer FoundationOTHER

17 Previous Clinical Trials

8,219 Total Patients Enrolled

3 Trials studying Prostate Cancer

558 Patients Enrolled for Prostate Cancer

Ross Halperin, MDStudy DirectorBritish Columbia Cancer Agency Program Director

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Prostate Cancer

60 Patients Enrolled for Prostate Cancer

Media Library

High dose rate prostate brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03426748 — N/A

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: NCT03426748 — N/A

High dose rate prostate brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03426748 — N/A

Frequently Asked Questions

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

To what extent have individuals enrolled in this clinical research?

"Affirmative. Clinicaltrials.gov has evidence that this clinical trial, which began on February 15th 2018 is actively recruiting candidates. Approximately 140 participants need to be accepted from one medical site."

Answered by AI

May I apply to participate in this investigation?

"Presently, this medical research requires 140 people with prostate cancer aged between 40 and 80 to take part. The main criteria for applicants include having an ECOG 0-1 rating, PSA levels under 10, Gleason 6 scores (or selected intermediate risk patients not specified above), as well as being classified T1c/T2a."

Answered by AI

Are individuals aged seventy-five and above able to register for this research program?

"The requirements for participants in this clinical trial stipulate that they must between 40 and 80 years of age. In contrast, there are 76 trials available to those under 18 and 1316 studies targeting the elderly population."

Answered by AI

Is this research endeavor currently recruiting participants?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical trial is currently open for enrollment, with the original post dating to February 15th 2018 and a recent update occurring October 15th 2020. 140 individuals are required from one site of research."

Answered by AI

Recent research and studies

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.

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.

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