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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
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 moreSide effects data
From 2020 Phase 2 trial • 35 Patients • NCT0207396871%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to nearby lymph nodes.My prostate cancer was confirmed through a biopsy within the last year.I have had a prostate exam in the last 90 days.I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or blood cancers.My cancer has spread to distant parts of my body.I have had radiation treatment in my pelvic area or seed implant therapy in my prostate.My prostate biopsy Gleason score is between 2-7, assessed within the last year.I do not have severe health issues like recent heart failure, serious infections, or severe lung problems.My prostate cancer is in an early stage and my PSA level is below 20 ng/mL.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 3 months.I have had surgery or specific treatments for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (proton beam radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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