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Proton Beam Therapy

Proton Beam Therapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Steven J Frank
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights

Study Summary

This trial studies the side effects and efficacy of proton beam radiation therapy in treating patients with localized prostate cancer.

Who is the study for?
Men with early-stage prostate cancer (Gleason score 2-7, stage T1-2b) and PSA <20 ng/mL can join this trial. They must have had a physical exam within the last 90 days and be in good health overall (Zubrod performance status 0-1). Prior invasive cancers, metastases, lymph node involvement, previous prostate surgeries or radiation treatments disqualify participation.Check my eligibility
What is being tested?
The study is testing hypofractionated proton beam therapy's effectiveness and side effects on localized prostate cancer. It involves delivering high doses of targeted radiation to minimize damage to healthy tissue. Participants will also undergo lab biomarker analysis and quality-of-life assessments.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, urinary issues such as increased frequency or discomfort, bowel changes like diarrhea or rectal bleeding, erectile dysfunction due to nerve damage around the prostate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 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
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
Secondary outcome measures
Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire
Incidence of rising prostate-specific antigen (PSA)
Rate of late toxicity
+2 more

Side effects data

From 2020 Phase 2 trial • 35 Patients • NCT02073968
71%
Cough
69%
Dysphagia
54%
Dermatitis
40%
Anorexia
23%
Constipation
11%
Dehydration
6%
Fatigue
6%
Nausea
6%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (proton beam radiation therapy)Experimental Treatment3 Interventions
Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,208 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,405 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
Steven J FrankPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
5,890 Total Patients Enrolled

Media Library

Hypofractionated Proton Beam Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01950351 — Phase 2
Prostate Cancer Research Study Groups: Treatment (proton beam radiation therapy)
Prostate Cancer Clinical Trial 2023: Hypofractionated Proton Beam Therapy Highlights & Side Effects. Trial Name: NCT01950351 — Phase 2
Hypofractionated Proton Beam Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01950351 — Phase 2

Frequently Asked Questions

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

Is this investigation currently open for enrolment?

"According to clinicaltrials.gov, this trial has suspended patient recruitment due to updates on October 6th 2022. However, 1969 other trials are currently seeking participants for their research initiatives."

Answered by AI

Does Proton Beam Radiation Therapy comply with FDA regulations?

"Due to its Phase 2 trial status, there is evidence of Proton Beam Radiation Therapy's safety but not efficacy. As such, our team at Power has rated it a 2 on the scale from 1 to 3."

Answered by AI
~24 spots leftby Jun 2025