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SABR vs EBRT for Prostate Cancer (ASSERT Trial)

N/A
Waitlist Available
Led By Winkle Kwan, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindication for 6 months and 18 months of androgen deprivation therapy respectively for intermediate and high risk disease
Disease must be Canadian Consensus (GUROC) high and intermediate risk with probability of pelvic nodal involvements <15% by the Updated Partin Tables
Must not have
Clinical evidence of extra-prostatic disease extension
Prior history of inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trialwill compare two radiation therapy techniques for prostate cancer. One is brachytherapy, an invasive treatment with excellent outcomes. The other is EBRT, more gentle but with poorer outcomes. SABR, with a few high dose treatments, is being tested for efficacy and safety.

Who is the study for?
Men with intermediate or high-risk prostate cancer, defined by specific clinical criteria such as Gleason score ≤7 and PSA ≤20 for intermediate risk, or ≥T3a, PSA >20, Gleason ≥8 for high risk. Participants must have a life expectancy of at least 5 years and be able to start radiation treatment within certain time frames after beginning hormone therapy. Exclusions include prior inflammatory bowel disease, hip prosthesis presence, evidence of extensive cancer spread beyond the prostate gland or large prostate volume.
What is being tested?
The ASSERT trial is comparing two types of radiation treatments: stereotactic ablative radiotherapy (SABR) which delivers a few high-dose treatments non-invasively and may be more effective than traditional methods; versus external beam radiation therapy (EBRT), which is gentler but prolonged over time. The study will assess toxicity rates, disease-free survival rates, and impacts on quality of life.
What are the potential side effects?
Potential side effects from SABR might include urinary issues like burning sensation during urination or increased frequency/urgency to urinate; rectal discomfort; fatigue; skin reactions in treated areas. EBRT could cause similar urinary and rectal symptoms along with potential sexual dysfunction due to its impact on the pelvic area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can undergo hormone therapy for 6 or 18 months without health risks.
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My prostate cancer is considered high or intermediate risk with a low chance of spread to pelvic nodes.
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My cancer is in an early stage (T1 or T2).
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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer has spread beyond the prostate.
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I have a history of inflammatory bowel disease.
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I have had radiation therapy to my pelvic area before.
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My cancer has spread to my pelvic nodes or further.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SABR with androgen suppressionExperimental Treatment2 Interventions
Stereotactic ablative radiotherapy (SABR) with a prescribed dose of 36.25 Gy in 5 fractions over 5 weeks (one treatment day per week). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
Group II: EBRT with androgen suppressionActive Control2 Interventions
Conventional external beam radiation therapy (EBRT) with a prescribed dose of 73.68 Gy in 28 fractions (5 treatment days per week over 5.5 weeks). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic ablative radiotherapy
2021
N/A
~10

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyOTHER
172 Previous Clinical Trials
90,524 Total Patients Enrolled
23 Trials studying Prostate Cancer
5,732 Patients Enrolled for Prostate Cancer
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,110 Total Patients Enrolled
10 Trials studying Prostate Cancer
3,059 Patients Enrolled for Prostate Cancer
Winkle Kwan, MDPrincipal InvestigatorBritish Columbia Cancer Agency

Media Library

External Beam Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02594072 — N/A
Prostate Cancer Research Study Groups: SABR with androgen suppression, EBRT with androgen suppression
Prostate Cancer Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02594072 — N/A
External Beam Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02594072 — N/A
~2 spots leftby Dec 2024
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