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.
Eligible Conditions
- Stage IIB Prostate Cancer
- Stage IVA Prostate Cancer
- Stage III Prostate Cancer
- Stage II Prostate Cancer
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIIA Prostate Cancer
- Stage IIIB Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 12 Secondary · Reporting Duration: Up to 5 years
At 2 years
Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
Month 60
Patient reported GI symptoms
Month 60
Patient reported GU symptoms
Up to 5 years
Biochemical failure (FFBF)
Biochemical progression-free survival
Distant metastases
Health economics
Local control
Loco-regional control
Patient reported quality of life outcomes
Prostate-cancer specific survival (PCSS)
Time to progression (TTP)
Time to salvage therapy
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Arm I (conventional radiation therapy)
1 of 2
Arm II (hypofractionated radiation therapy)
1 of 2
Active Control
Experimental Treatment
178 Total Participants · 2 Treatment Groups
Primary Treatment: Hypofractionated Radiation Therapy · No Placebo Group · Phase 3
Arm II (hypofractionated radiation therapy)Experimental Group · 3 Interventions: Questionnaire Administration, Quality-of-Life Assessment, Hypofractionated Radiation Therapy · Intervention Types: Other, Other, Radiation
Arm I (conventional radiation therapy)ActiveComparator Group · 3 Interventions: Questionnaire Administration, Quality-of-Life Assessment, Radiation Therapy · Intervention Types: Other, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,293 Total Patients Enrolled
32 Trials studying Stage IIB Prostate Cancer
1,990 Patients Enrolled for Stage IIB Prostate Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,201 Total Patients Enrolled
Quynh-Nhu NguyenPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
238 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Male Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy
You have pathologic T2-T3M0 stage.
Pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of >= 0.1
Patients may receive 6 months and up to 24 months of androgen deprivation therapy
You have a prior history of any cancer other than prostate cancer, and you must have completed treatment within 1 year of study registration.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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Conditions
Cancer Related
Treatments