← Back to Search

Proton Beam Therapy

"Spot Delete" for Prostate Cancer

Q: What is the current number of participants being recruited for this clinical study?

<p>Indeed, the details provided on clinicaltrials.gov indicate that this study is actively seeking eligible participants. The trial was initially posted on January 8th, 2024 and underwent its last revision on December 27th, 2023. A total of 500 patients are being admitted to participate in this trial across a single site.</p>

Q: Are patients currently eligible to enroll in this research study?

<p>Indeed, the information available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted on January 8th, 2024 and last updated on December 27th, 2023. In total, the study aims to enroll 500 patients from a single site.</p>

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

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

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am fully active or can carry out light work.

Select...

I am 18 years old or older.

Select...

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

Select...

I have been diagnosed with prostate cancer.

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

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

Primary outcome measures

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

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thompson Cancer Survival CenterLead Sponsor

3 Previous Clinical Trials

300 Total Patients Enrolled

Samantha Hedrick, PhD, DABRPrincipal InvestigatorThompson Proton Center

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of participants being recruited for this clinical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this study is actively seeking eligible participants. The trial was initially posted on January 8th, 2024 and underwent its last revision on December 27th, 2023. A total of 500 patients are being admitted to participate in this trial across a single site."

Answered by AI

Are patients currently eligible to enroll in this research study?

"Indeed, the information available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted on January 8th, 2024 and last updated on December 27th, 2023. In total, the study aims to enroll 500 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

2024. "Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06200259.

All > Toxicity > Knoxville