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SABR vs EBRT for Prostate Cancer (ASSERT Trial)

N/A

Waitlist Available

Led By Abraham Alexander, 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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met