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radiation therapy for Prostate Cancer

Phase 3
Waitlist Available
Led By William U. Shipley, MD
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to 12 years.
Awards & highlights

Study Summary

This trial is looking at whether radiation therapy is more effective with or without bicalutamide for prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to four years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to four 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
Overall Survival (12-year Rates Reported)
Secondary outcome measures
Distant Failure (12-year Rates Reported)
Grade 3+ Toxicity
Non-Prostate Cancer Death (12-year Rates Reported)
+5 more

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597
44%
Acute RT Toxicity: Bowel: NOS
29%
Hormone Toxicity: Hot flashes : NOS
26%
Late RT Toxicity: Bowel: NOS
24%
Hormone Toxicity: Impotence : NOS
18%
Late RT Toxicity: Bladder: NOS
17%
Hormone Toxicity: Hematologic : NOS
15%
Acute RT Toxicity: Bladder: NOS
13%
Acute RT Toxicity: Hematologic: NOS
13%
Late RT Toxicity: Hematologic: NOS
13%
Acute RT Toxicity: Other: NOS
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BicalutamideExperimental Treatment2 Interventions
Radiation therapy + bicalutamide
Group II: PlaceboPlacebo Group2 Interventions
Radiation therapy + placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bicalutamide
2007
Completed Phase 4
~12250
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
260,971 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,710 Patients Enrolled for Prostate Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,012 Total Patients Enrolled
19 Trials studying Prostate Cancer
11,461 Patients Enrolled for Prostate Cancer
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,087 Total Patients Enrolled
32 Trials studying Prostate Cancer
19,751 Patients Enrolled for Prostate Cancer

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 With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
1998. "Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00002874.
~31 spots leftby Apr 2025
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