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Radiation
SBRT for Prostate Cancer
Phase 1
Recruiting
Led By Jonathan Lischalk
Research Sponsored by NYU Langone Health
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 year 5 post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new prostate cancer treatment that uses radiation in two doses to safely treat localized prostate cancer.
Who is the study for?
This trial is for men over 18 with localized prostate cancer, staged TX-T2c. They must have a prostate size under 60cc, no prior malignancies within the last 5 years, and agree to use effective contraception. Excluded are those with evidence of more advanced cancer spread, large prostates over 60cc, recent prostate surgeries or treatments affecting the pelvis.
What is being tested?
The study tests a two-session Stereotactic Body Radiation Therapy (SBRT) targeting a dominant lesion in the prostate using MRI guidance. It's designed to see if this focused treatment is feasible and safe for patients with early-stage prostate cancer.
What are the potential side effects?
While not explicitly listed here, potential side effects may include urinary issues, bowel discomfort due to radiation exposure near these areas, fatigue from therapy sessions and skin reactions at the site of radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to year 5 post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 5 post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Secondary study objectives
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
Disease-Free Survival (DFS)
Incidence of Phoenix Definition Biomechanical Failure (BCF)
+3 moreAwards & 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: Men with low to intermediate risk prostate cancerExperimental Treatment1 Intervention
Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,663 Total Patients Enrolled
26 Trials studying Prostate Cancer
5,235 Patients Enrolled for Prostate Cancer
Jonathan LischalkPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My treatment plan doesn't meet specific safety limits for radiation exposure.I have had a uro lift procedure before.My condition is considered high risk.My doctor says I need radiation therapy for my lymph nodes to prevent cancer spread.My cancer has spread beyond the original organ.I have not had any other cancers in the last 5 years.My prostate is larger than 60cc according to my MRI.My prostate cancer was confirmed through a biopsy.I have had radiation treatment to my pelvic area.I have had surgery on my prostate before.I have an active severe inflammatory or rheumatological condition.My cancer is considered low to intermediate risk.I am a man willing to use contraception during the study.My prostate is smaller than 60cc according to my MRI.My doctor will decide if I need hormone therapy for my cancer.My cancer is considered low to intermediate risk and does not require an SIB.My cancer is not highly aggressive.My radiation oncologist says I need a specific procedure for my rectal area.My cancer is between stages TX and T2c according to the 8th edition staging.My prostate cancer is localized and not spread.I had a prostate surgery (TURP) within the last 6 months.My cancer has spread to the lymph nodes in my pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Men with low to intermediate risk prostate cancer
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.
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