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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

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,002 Previous Clinical Trials

1,794,101 Total Patients Enrolled

96 Trials studying Prostate Cancer

29,740 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,223 Total Patients Enrolled

566 Trials studying Prostate Cancer

529,005 Patients Enrolled for Prostate Cancer

Quynh-Nhu NguyenPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

238 Total Patients Enrolled

Media Library

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

~35 spots leftby Nov 2025

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