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Radiation Therapy

Radiation Therapy for Prostate Cancer

Phase 3
Recruiting
Led By Quynh-Nhu Nguyen
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
If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer
Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether delivering radiation in higher doses over a shorter time period is more effective at treating prostate cancer with fewer side effects.

Who is the study for?
Men aged 18+ with prostate cancer, Gleason score 6-10, and stage T2-T3M0 can join. They may have up to 5 metastatic pelvic lymph nodes and must have had a radical prostatectomy. Eligible if they've received or will receive hormone therapy for up to 24 months but no prior radiation in the target area or severe co-morbidities like lupus, uncontrolled diabetes, recent heart issues, severe liver disease.Check my eligibility
What is being tested?
The trial compares two types of radiation therapy for prostate cancer: conventional (standard doses over a longer period) versus hypofractionated (higher doses over a shorter period). It aims to see which is more effective at killing tumor cells with fewer side effects.See study design
What are the potential side effects?
Radiation therapy might cause skin irritation at the treatment site, fatigue, urinary issues such as increased frequency or urgency, bowel changes like diarrhea or discomfort, and potential sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had cancer other than prostate, treated over a year ago, with no current signs of that cancer.
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I have prostate cancer and had surgery to remove my prostate.
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My cancer is at stage T2-T3M0 and may have up to 5 pelvic lymph nodes involved.
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I am able to get out of my bed or chair and move around.
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My prostate cancer has a Gleason score between 6 and 10.
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I am a man aged 18 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
Secondary outcome measures
Biochemical failure (FFBF)
Biochemical progression-free survival
Distant metastases
+9 more

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802
80%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (hypofractionated radiation therapy)Experimental Treatment3 Interventions
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
Group II: Arm I (conventional radiation therapy)Active Control3 Interventions
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,364 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,715 Previous Clinical Trials
40,953,659 Total Patients Enrolled
565 Trials studying Prostate Cancer
529,064 Patients Enrolled for Prostate Cancer
Quynh-Nhu NguyenPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
238 Total Patients Enrolled

Media Library

Prostate Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03987386 — Phase 3

Frequently Asked Questions

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

Has Hypofractionated Radiation Therapy undergone approval by the US Federal Drug Administration?

"There is both supporting efficacy data and multiple rounds of safety data, so Hypofractionated Radiation Therapy received a score of 3."

Answered by AI

How many people are currently participating in this research?

"That is accurate. The information available on clinicaltrials.gov shows that this clinical trial is still looking for participants. It was originally posted on 5/30/2019, and the most recent update was on 9/29/2022. They are hoping to have 178 people join from 3 different sites."

Answered by AI

Are patients currently being enrolled in this trial?

"That is accurate. The information available on clinicaltrials.gov affirms that this trial, which was first publicized on May 30th 2019, is still looking for participants. There are 3 different hospitals where a total of 178 patients can be enrolled in the study."

Answered by AI
~39 spots leftby Nov 2025