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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
Must not have
History of severe active co-morbidity or uncontrolled diabetes
Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe health issues or uncontrolled diabetes.
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I have had radiation therapy to my prostate or nearby areas.
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I have received chemotherapy before or after surgery to remove my prostate.
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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.
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I am on dialysis or have been advised to start dialysis.
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I have a history of lupus, scleroderma, or CREST syndrome.
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I do not have severe liver disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
Secondary study objectives
Biochemical progression-free survival
Health economics
Patient reported GI symptoms
+5 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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
3,065 Previous Clinical Trials
1,802,070 Total Patients Enrolled
88 Trials studying Prostate Cancer
28,628 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,287 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 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
~25 spots leftby Nov 2025
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