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Proton Beam Therapy

Proton Therapy Spot Placement for Prostate Cancer

N/A

Recruiting

Led By Samantha Hedrick, PhD, DABR

Research Sponsored by Thompson Cancer Survival Center

Eligibility Criteria Checklist

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

Must have

Gleason Score ≤ 7

Eastern Cooperative Oncology Group (ECOG) Performance status 0-1

Must not have

Prior radiotherapy to the pelvic area

Prior prostate cancer therapy: cryotherapy or hyperthermia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the placement of proton spots during proton therapy for prostate cancer. The researchers will be using a technique called "Spot Delete" to control the placement of spots during treatment planning. They

Who is the study for?

Men over 18 with low to intermediate risk prostate cancer, not previously treated with pelvic radiotherapy, cryotherapy, hyperthermia or chemotherapy. They must have a clinical stage T1-T2c prostate cancer, PSA < 20 ng/mL, Gleason Score ≤ 7 and be in good physical condition (ECOG status 0-1). Participants should also be willing to complete quality of life surveys.

What is being tested?

The trial is testing 'Spot Delete' planning for proton therapy against traditional methods. It aims to reduce side effects by avoiding proton spots in sensitive areas like the rectum and bowel during treatment for prostate cancer.

What are the potential side effects?

Potential side effects may include acute or late toxicities such as tenesmus (rectal cramping), diarrhea, fecal incontinence, proctitis (inflammation of the rectum lining), and rectal hemorrhage due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has a Gleason score of 7 or less.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My breast cancer is in an early stage (T1-T2c).

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I have been diagnosed with prostate cancer.

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 cryotherapy or hyperthermia for prostate cancer.

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I have received chemotherapy for prostate cancer.

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I have active diverticulitis, ulcerative colitis, or Crohn's disease.

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My treatment targets lymph nodes in the pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, during treatment, at the end of treatment, and annually up to 10 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

Test the hypothesis that "Spot Delete" technique in proton therapy reduces late toxicity in low- and intermediate-risk prostate cancer patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: "Spot Delete"Experimental Treatment1 Intervention

A unique technique called "Spot Delete" will be utilized to control the placement of spots during treatment planning, to prohibit proton spots from being placed in the rectum, sigmoid, and small bowel. A specialized computer model will be used to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects.

Group II: Control ArmActive Control1 Intervention

The proton spots that are placed by the treatment planning system are not modified

0 / 10Eligibility criteria met