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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
Must not have
Regional lymph node involvement
Evidence of distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to nearby lymph nodes.
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My cancer has spread to distant parts of my body.
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I have had radiation treatment in my pelvic area or seed implant therapy in my prostate.
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I do not have severe health issues like recent heart failure, serious infections, or severe lung problems.
Select...
I have had surgery or specific treatments for prostate cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity
Secondary study objectives
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%
Pneumonitis
6%
Fatigue
6%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,074 Previous Clinical Trials
1,803,106 Total Patients Enrolled
88 Trials studying Prostate Cancer
28,628 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,846 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 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
~9 spots leftby Jun 2025
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