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Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT)

NCT02594072 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-29

No results posted yet for this study

Summary

Two radiation therapy techniques are commonly used for the treatment of intermediate and high risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate, produces excellent outcomes but is invasive and not all patients are eligible or willing to receive this treatment. EBRT, while gentle at the time of delivery, tends to be very prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose radiation treatments. Treatments are short, non-invasive, applicable to patients not able to do brachytherapy, and may be more effective than conventional EBRT. This study will compare SABR with EBRT in terms of the rates of acute and late toxicities for each treatment, disease-free survival, and health-related quality of life measures.

Conditions

Interventions

RADIATION

stereotactic ablative radiotherapy

Linac-based prostate stereotactic radiotherapy, using Volumetric Modulated Arc Therapy planning and delivery, with fiducial marker and cone-beam CT based image guidance.

RADIATION

external beam radiation therapy

Conventional intensity modulated radiotherapy, with fiducial marker or cone-beam CT based image guidance.

DRUG

Zoladex ®

The preferred agent for the protocol is goserelin acetate (Zoladex ®) 3-month depot, but other LHRH agonists are permitted. The total duration of ADT will be 6 months for men with intermediate risk disease, and 18 months for those with high risk disease. ADT is to be initiated prior to the start of RT.

Sponsors & Collaborators

  • British Columbia Cancer Agency

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Abraham Alexander, MD · British Columbia Cancer Agency

  • Winkle Kwan, MD · British Columbia Cancer Agency

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594072 on ClinicalTrials.gov