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Rectal Hydrogel Spacer for Prostate Cancer (FIRST STAR Trial)

N/A
Recruiting
Led By Amandeep Taggar, MD
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
Histologically and radiologically confirmed locally recurrent prostate adenocarcinoma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights

FIRST STAR Trial Summary

This trial is studying if a hydrogel spacer between prostate and rectum can lower radiation damage and improve bowel quality of life in patients receiving second course of radiation.

Who is the study for?
This trial is for men with prostate cancer that has come back locally and can be seen on scans. They must be able to fill out health questionnaires and agree to join the study. Men are excluded if they have resistant cancer, spread of cancer outside the pelvis, previous high-dose radiation therapy, bleeding disorders, poor urinary function, MRI contraindications or cannot stop blood thinners safely.Check my eligibility
What is being tested?
The trial tests a biodegradable gel called SpaceOAR placed between the prostate and rectum during salvage SABR (a type of focused radiation therapy) to reduce bowel side effects and improve quality of life in patients undergoing re-irradiation for recurrent prostate cancer.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from gel placement procedure, possible increased risk of infection due to an additional procedure, and typical risks associated with radiation such as mild skin reactions or temporary changes in bowel habits.

FIRST STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has come back in the same area and has been confirmed by tests.

FIRST STAR Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of SpaceOAR
Secondary outcome measures
Acute Coryza
Biochemical disease-free survival
Health utilities
+3 more

FIRST STAR Trial Design

1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
All patients with local recurrence of prostate cancer post irradiation will undergo placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life prior to SABR.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,287 Total Patients Enrolled
33 Trials studying Prostate Cancer
12,252 Patients Enrolled for Prostate Cancer
Amandeep Taggar, MDPrincipal InvestigatorSunnybrook

Media Library

Study Arm Clinical Trial Eligibility Overview. Trial Name: NCT05597852 — N/A
Prostate Cancer Research Study Groups: Study Arm
Prostate Cancer Clinical Trial 2023: Study Arm Highlights & Side Effects. Trial Name: NCT05597852 — N/A
Study Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597852 — 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 open for this research experiment?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical research is actively enrolling participants, having been released to the public on November 30th 2021 and last modified October 25th 2022. The study requires 10 patients from a single location."

Answered by AI

What is the sample size for this particular research endeavor?

"Affirmative. Clinicaltrials.gov outlines that this medical trial, which commenced on November 30th 2021, is actively recruiting volunteers. 10 participants are expected to be enrolled from 1 site in total."

Answered by AI
~3 spots leftby Mar 2025