← Back to Search

Radiation Therapy

Radiation Therapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Brian J. Davis, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes
Histological confirmation of prostate adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration until the death due to any cause, assessed at 2 and 5 years
Awards & highlights

Study Summary

This trial is testing whether a shorter course of radiation therapy is better for patients with recurrent prostate cancer, with fewer side effects.

Who is the study for?
Men over 18 with recurrent prostate cancer limited to certain lymph nodes, who've had primary radiotherapy. They must have a good performance status (able to carry out daily activities) and no bone or visceral metastases, other recent malignancies, or conditions that prevent radiation therapy or informed consent.Check my eligibility
What is being tested?
The trial is testing two types of radiation: Hypofractionated Proton Beam Therapy which gives smaller doses over time, and IMRT which uses high-energy x-rays. The goal is to see if a shorter course of radiation can effectively treat recurrent prostate cancer with fewer side effects.See study design
What are the potential side effects?
Potential side effects include skin reactions in the treated area, fatigue, bowel and bladder issues such as diarrhea or increased frequency of urination, erectile dysfunction, and possibly inflammation of surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is only in my pelvic or nearby lymph nodes.
Select...
My prostate cancer has been confirmed through a biopsy.
Select...
I am a man aged 18 or older.
Select...
My prostate cancer has returned after I had radiation therapy.
Select...
My cancer has returned and spread to my lymph nodes, confirmed by advanced PET scans.
Select...
My cancer has spread but only to a few places.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration until the death due to any cause, assessed at 2 and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration until the death due to any cause, assessed at 2 and 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
Proportion of patients who experience a late (>= 90 days after radiation therapy [RT] start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE)
Secondary outcome measures
Incidence of acute adverse events
Incidence of adverse events
Incidence of late adverse events
+1 more
Other outcome measures
Disease-free survival
Disease-specific survival
Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire
+1 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741
30%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Vascular access complication
10%
Wound dehiscence
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (IMRT)Experimental Treatment5 Interventions
Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
Group II: Arm I (proton beam radiation therapy)Experimental Treatment6 Interventions
Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,700 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,388 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,069 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Brian J. Davis, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Prostate Cancer
8 Patients Enrolled for Prostate Cancer

Media Library

Intensity-Modulated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04190446 — Phase 2
Prostate Cancer Research Study Groups: Arm I (proton beam radiation therapy), Arm II (IMRT)
Prostate Cancer Clinical Trial 2023: Intensity-Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04190446 — Phase 2
Intensity-Modulated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04190446 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment
2020. "Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04190446.
All > Recurrent Prostate Cancer
~11 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top