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Stereotactic Body Radiation Therapy for Prostate Cancer

Phase 1
Waitlist Available
Led By Sagus Sampath
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how to safely use radiation to treat prostate cancer after surgery, aiming to limit damage to healthy tissue.

Who is the study for?
Men who've had prostate cancer surgery can join this trial. They should be in decent physical shape (ECOG 0-2), have no signs of cancer spread based on recent scans, and a PSA level up to 2.0. Men with certain high-risk features from their surgery are also eligible. Those with uncontrolled illnesses, other cancers within the last 5 years (except skin cancer), or taking experimental treatments can't join.
What is being tested?
The trial is testing how safe and effective stereotactic body radiation therapy is for prostate cancer patients post-surgery. It's looking for the best dose that targets the tumor while sparing healthy tissue, alongside assessing quality-of-life and analyzing biomarkers.
What are the potential side effects?
Stereotactic body radiation may cause side effects like fatigue, skin reactions at the treatment site, urinary issues, bowel discomfort, and erectile dysfunction due to its focus on areas affected by prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Secondary study objectives
Biochemical progression-free survival
Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
+1 more

Side effects data

From 2016 Phase 2 trial • 59 Patients • NCT00087438
55%
Dyspnea
38%
Fatigue
33%
Cough
24%
Hemoglobin
20%
Pulmonary/upper respiratory - Other
16%
Chest wall pain
16%
Fracture NOS
16%
Forced expiratory volume
15%
Nausea
15%
Chest pain
15%
Pneumonitis NOS
11%
Blood/bone marrow - Other
11%
Dermatitis radiation NOS
11%
Blood creatinine increased
9%
Pleural effusion
9%
Vomiting NOS
9%
Hyperglycemia NOS
9%
Hypoalbuminemia
9%
Lymphopenia
9%
Pulmonary function test NOS decreas
7%
Hypocalcemia
7%
Abdominal pain NOS
7%
Headache
7%
Hypoxia
7%
Edema: limb
7%
Blood bilirubin increased
7%
Peripheral sensory neuropathy
5%
Pyrexia
5%
Atrial fibrillation
5%
Diarrhea NOS
5%
Hypokalemia
5%
Muscle weakness NOS
5%
Rigors
5%
Myalgia
5%
Musculoskeletal/soft tissue - Other
5%
Hyponatremia
5%
Pain - Other
5%
Infection with Grade 3 or 4 neutrop
5%
Activated partial thromboplastin ti
5%
Blood alkaline phosphatase increase
5%
Metabolic/laboratory - Other
5%
Weight decreased
5%
Renal/genitourinary - Other
5%
Atelectasis
4%
Anorexia
2%
Dysphagia
2%
Lymphatics - Other
2%
Pulmonary hypertension NOS
2%
Cardiac general - Other
2%
Constipation
2%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy (SBRT)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT)Experimental Treatment3 Interventions
Patients receive 5 fractions of SBRT over 1.5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic body radiation therapy
2019
Completed Phase 2
~480
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,350 Total Patients Enrolled
15 Trials studying Prostate Cancer
5,633 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,911 Total Patients Enrolled
569 Trials studying Prostate Cancer
529,860 Patients Enrolled for Prostate Cancer
Sagus SampathPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials

Media Library

stereotactic body radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT01923506 — Phase 1
Prostate Cancer Research Study Groups: Treatment (SBRT)
Prostate Cancer Clinical Trial 2023: stereotactic body radiation therapy Highlights & Side Effects. Trial Name: NCT01923506 — Phase 1
stereotactic body radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01923506 — Phase 1
~0 spots leftby Dec 2024
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