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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

ASSERT Trial 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.Check my eligibility
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.See study design
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.

ASSERT Trial 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.

ASSERT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Number of subjects experiencing treatment-related acute and late toxicities, focussing on grade 3 and 4 complications, as assessed by the NCI CTCAEv4 and modified RTOG/SOMA toxicity scale.
Secondary outcome measures
Number of subjects with biochemical relapse free survival at five years as measured by PSA levels.
To compare the health related quality of life as reflected in changes on the EPIC questionnaire between the two interventions
To measure the mean prostate pre-fraction to post-fraction displacement, in millimeters, from CT scans done pre- and post-fraction.

ASSERT 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?

University of British ColumbiaLead Sponsor
1,407 Previous Clinical Trials
1,766,469 Total Patients Enrolled
9 Trials studying Prostate Cancer
2,683 Patients Enrolled for Prostate Cancer
British Columbia Cancer AgencyOTHER
171 Previous Clinical Trials
90,431 Total Patients Enrolled
23 Trials studying Prostate Cancer
5,732 Patients Enrolled for Prostate Cancer
Abraham Alexander, 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

Frequently Asked Questions

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

In what circumstances is SABR with androgen suppression typically employed?

"Radiotherapy is typically administered with SABR and hormone inhibition. In some cases, this technique may also be beneficial for palliative therapy, endometrial thinning, as well as uterine bleeding."

Answered by AI

Are there any remaining vacancies for participants in this clinical research?

"According to the information found on clinicaltrials.gov, this investigation is no longer accepting participants; although it was initially posted on April 1st 2016 and updated last October 31st 2022. Nevertheless, 1389 other medical trials are enrolling volunteers presently."

Answered by AI

What is the size of the sample population for this research initiative?

"Unfortunately, this study is not currently recruiting. The trial was first published on April 1st 2016 and the most recent update to its information occurred on October 31 2022. If you are in search of alternative studies, 1322 trials involving prostate cancer patients and 67 clinical trials concerning SABR with androgen suppression are presently looking for participants."

Answered by AI

Is this the inaugural trial of its type?

"Since 2000, SABR with androgen suppression has been a focus for medical research. AstraZeneca initially sponsored the clinical trial in 2000 which involved 600 people. After successful completion of Phase 3 trials this therapy became approved as an official drug treatment option. Currently there are 67 active studies related to SABR with androgen suppression spanning 1327 cities over 50 nations worldwide."

Answered by AI
~6 spots leftby Dec 2024