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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2016 Phase 2 trial • 59 Patients • NCT0008743855%
Dyspnea
38%
Fatigue
33%
Cough
24%
Hemoglobin
20%
Pulmonary/upper respiratory - Other
16%
Chest wall pain
16%
Fracture NOS
16%
Forced expiratory volume
15%
Pneumonitis NOS
15%
Chest pain
15%
Nausea
11%
Blood/bone marrow - Other
11%
Dermatitis radiation NOS
11%
Blood creatinine increased
9%
Hypoalbuminemia
9%
Vomiting NOS
9%
Hyperglycemia NOS
9%
Pleural effusion
9%
Lymphopenia
9%
Pulmonary function test NOS decreas
7%
Edema: limb
7%
Abdominal pain NOS
7%
Hypocalcemia
7%
Headache
7%
Hypoxia
7%
Blood bilirubin increased
7%
Peripheral sensory neuropathy
5%
Pyrexia
5%
Rigors
5%
Diarrhea NOS
5%
Musculoskeletal/soft tissue - Other
5%
Muscle weakness NOS
5%
Myalgia
5%
Hypokalemia
5%
Atrial fibrillation
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%
Insomnia
2%
Lymphatics - Other
2%
Cardiac general - Other
2%
Constipation
2%
Pulmonary hypertension NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy (SBRT)
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
565 Previous Clinical Trials
1,921,434 Total Patients Enrolled
14 Trials studying Prostate Cancer
5,613 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,127 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Sagus SampathPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is stereotactic body radiation therapy a safe procedure for patients to undergo?
"Based on available evidence, we have assigned stereotactic body radiation therapy a score of 1. This is due to this being within the confines of a Phase 1 trial which has unreliable safety and efficacy data."
Answered by AI
Are participants being recruited for this investigation presently?
"As indicated by clinicaltrials.gov, this medical study has ceased to recruit new participants since November 22nd 2022. Nevertheless, there are 1252 other trials now recruiting patients nationwide."
Answered by AI
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