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Proton Beam Therapy

Radiotherapy Techniques for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Scott Tyldesley

Eligibility Criteria Checklist

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

Must have

ECOG performance Status: 0-2

Age ≥ 18

Must not have

Prior pelvic radiotherapy

Prior transurethral resection of prostate or radical prostatectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up accrual period, estimated 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the side effects of two radiation techniques: standard non-adaptive radiation therapy and daily adaptive radiation therapy. They are also looking at the effects of different bladder filling instructions to see if personalized

Who is the study for?

This trial is for individuals with intermediate or high risk localized prostate cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have no conditions that could interfere with the study.

What is being tested?

The study compares side effects of two radiation techniques: standard non-adaptive therapy versus daily adaptive therapy. It also examines if customized bladder filling instructions improve treatment outcomes for prostate cancer patients.

What are the potential side effects?

While specific side effects are not listed, radiation therapy can generally cause fatigue, skin reactions in treated areas, urinary issues, bowel changes, and sexual dysfunction among others.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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My prostate cancer is at an intermediate or high risk stage but hasn't spread.

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My cancer is a type of prostate cancer called adenocarcinoma.

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My prostate cancer is high risk based on its stage, PSA level, or Gleason score.

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I have agreed to a specific radiation therapy plan for my prostate and pelvic nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my pelvic area before.

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I have had surgery for prostate cancer.

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I have had radiation therapy to my pelvic area before.

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I use more than one soaked pad or two dry pads daily due to urinary incontinence.

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I can't stay still for over 30 minutes on a treatment couch.

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My cancer is at a stage where it has grown significantly or spread to nearby tissues.

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I have a kidney located in my pelvis.

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I have a connective tissue disorder, but it's not rheumatoid arthritis.

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My cancer has spread to other parts of my body.

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I am not willing to use effective birth control methods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ accrual period, estimated 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~accrual period, estimated 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and accrual period, estimated 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.

Secondary study objectives

Determine which BFIs are associated with least rescan and repeat CBCT requirements

Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time

Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.

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