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Rectal Spacer Hydrogel for Prostate Cancer

N/A
Waitlist Available
Led By Richard Stock
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG score of 0-2
Age >18
Must not have
High-risk prostate cancer with GS >= 8, PSA > 20, clinical or imaging stage T3a or higher
Previous rectal, bowel, bladder, or prostate surgeries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 2 years post-treatment
Awards & highlights

Summary

This trial tests whether rectal spacer hydrogel can reduce radiation dose to the rectum in patients with prostate cancer.

Who is the study for?
This trial is for men aged 18-100 with intermediate-risk prostate cancer that hasn't spread beyond the prostate. They must be medically suitable for rectal spacer placement and radiation therapy, have a KPS score of ≥70%, and not have had certain previous surgeries or treatments for prostate cancer.Check my eligibility
What is being tested?
The trial evaluates if injecting a hydrogel called rectal spacer before radiation can protect the rectum from radiation damage in prostate cancer treatment. The gel creates space between the rectum and prostate during stereotactic body radiation therapy and brachytherapy.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, possible reaction to materials in the gel, temporary urinary changes, or bowel movement alterations due to the presence of the hydrogel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and move around.
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I am older than 18 years.
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My prostate cancer is at an intermediate risk stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer is high-risk with a Gleason score of 8 or higher, PSA over 20, or it has grown beyond the prostate.
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I have had surgery on my rectum, bowel, bladder, or prostate.
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My prostate is larger than 100 cc according to scans.
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I have had radiation therapy to my pelvic area before.
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My prostate cancer has spread beyond the prostate.
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I have had treatments for prostate cancer or am currently on experimental therapies.
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I am currently on hormone therapy for cancer.
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I have had cancer in my urinary or genital area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 2 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of participants that achieve V100rectum < 0.75 cc
Secondary outcome measures
Change in Expanded Prostate Cancer Index Composite (EPIC)
Change in International Prostate Symptom Score (IPSS)
Change in Sexual Health Index in Men (SHIM)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with prostate cancerExperimental Treatment5 Interventions
Patients undergo hydrogel rectal spacer placement on day 1. Within 2 weeks (+/-1 week) after Rectal Spacer placement, patients will be scheduled for CT simulation for external beam treatment planning. Patients will begin the SBRT of 24Gy in 5 fractions within 2 weeks (+/-1 week) from the simulation date. Within 4 weeks (+/-1 week) of last day of SBRT, patients undergo brachytherapy. Patient will return for post-implant CT-based dosimetry analysis 4 weeks (+/- 1 week) post brachytherapy,
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Device Usage and Evaluation
2021
N/A
~150
CT simulation
2016
N/A
~170
Stereotactic body radiation therapy
2017
Completed Phase 1
~30
Brachytherapy
2007
Completed Phase 3
~2100

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,215 Total Patients Enrolled
11 Trials studying Prostate Cancer
23,828 Patients Enrolled for Prostate Cancer
Richard StockPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Stereotactic body radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT05224869 — N/A
Prostate Cancer Research Study Groups: Patients with prostate cancer
Prostate Cancer Clinical Trial 2023: Stereotactic body radiation therapy Highlights & Side Effects. Trial Name: NCT05224869 — N/A
Stereotactic body radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224869 — N/A
~6 spots leftby Dec 2024
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