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Radiation Therapy

SABR for Prostate Cancer

N/A

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of metastatic, castration-resistant prostate cancer

ECOG performance status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial is exploring the use of SABR to treat men with prostate cancer who have oligoprogressive metastases.

Who is the study for?

This trial is for men with prostate cancer that's spread but mostly under control while on abiraterone, except for up to 5 'rogue' tumors getting worse. They should be fairly active (ECOG 0-1), have a confirmed diagnosis, and all progressing spots can be targeted by SABR. Men with spinal cord compression, recent cancers besides skin or in-situ types, or severe symptoms needing immediate other treatments can't join.Check my eligibility

What is being tested?

The study tests if Stereotactic Ablative Radiation Therapy (SABR) can target few worsening metastases in prostate cancer patients resistant to abiraterone without changing their current systemic therapy. The goal is to see if this approach delays the need for new systemic treatments and helps control the disease longer.See study design

What are the potential side effects?

SABR may cause side effects like fatigue, skin reactions at the treatment site, nausea, urinary issues due to inflammation of bladder or urethra, bowel discomfort from intestinal irritation and potential damage to nearby organs depending on where radiation targets.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has spread and is not responding to hormone therapy.

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I am fully active or can carry out light work.

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I am currently being treated with abiraterone.

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My prostate cancer has been confirmed through a biopsy.

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My cancer is spreading slowly, with 5 or fewer new spots.

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My cancer spread can be treated with targeted radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival

SABR-related toxicities

Secondary outcome measures

Biochemical progression-free survival

Overall survival

Quality of Life (QoL) assessment

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

All metastases that fulfill the definition of oligoprogression seen on conventional imaging will be treated with standard SABR dose fractionation schemes routinely used at Sunnybrook Odette Cancer Centre. The prostate (if present and not previously treated) will be treated to a dose of 35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Spine metastases will be treated to a dose of 24 Gy in 2-3 fractions or 30-40 Gy in 5 fractions. Involved lymphadenopathy will be treated to a dose of 30-40 Gy in 5 fractions. Similarly, brain, lung, liver, and adrenal metastases will be treated with standard Sunnybrook SABR doses. Patients will remain on abiraterone during and after SABR treatments.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,647 Total Patients Enrolled

35 Trials studying Prostate Cancer

12,638 Patients Enrolled for Prostate Cancer

Media Library

Stereotactic Body Radiation Therapy (SABR) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04838899 — N/A

Prostate Cancer Research Study Groups: Treatment Arm

Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SABR) Highlights & Side Effects. Trial Name: NCT04838899 — N/A

Stereotactic Body Radiation Therapy (SABR) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838899 — N/A

Frequently Asked Questions

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

Is recruitment currently underway for this trial?

"According to clinicaltrials.gov, this research venture is currently seeking participants. It was initially published on July 16th 2016 and most recently updated on April 9th 2021."

Answered by AI

What is the aggregate participation rate for this research endeavor?

"Correct. The clinical trial is currently open for participation, as indicated on the information hosted by clinicaltrials.gov, with a first posting date of July 16th 2016 and last edit of April 9th 2021. A total of 30 patients are required from one medical centre."

Answered by AI

What outcomes are researchers aiming for in this experiment?

"This 12-month study primarily focuses on the progression-free survival of patients. The secondary objectives are to measure radiographic local control rate, biochemical progression-free survial, as well as time to changing systemic therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer

Dr. Urban Emmenegger 2016. "Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04838899.

All > Canada Prostate Cancer > Metastatic Prostate Cancer