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Proton Beam Therapy

High-Dose Radiotherapy for Prostate Cancer (PROSINT Trial)

Phase 2
Waitlist Available
Led By Madhur Garg, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gleason score 7
Histologic confirmation of adenocarcinoma of the prostate by biopsy
Must not have
Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
Tumour Clinical stage T3 or T4 on MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants should be followed continuously for the duration of 5 years
Awards & highlights
Approved for 60 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is evaluating treatment outcomes for prostate cancer patients classified as intermediate risk, comparing two different regimens of external beam radiotherapy.

Who is the study for?
Men over 50 with intermediate-risk prostate cancer, which means a Gleason score of 7, PSA levels between >10 and ≤20 ng/mL, and no evidence of spread beyond the prostate. They must have good performance status (able to carry out daily activities), a prostate size ≤100 grams, and an International Prostate Symptom Score ≤15.
What is being tested?
The study is testing two high-dose radiation treatments using IGRT technology for men with intermediate-risk prostate cancer. One group will receive a single dose of 24 Gy; another will get five doses at 9 Gy each. The trial aims to compare outcomes and side effects like urinary, rectal, and sexual function.
What are the potential side effects?
Potential side effects include issues related to urinary functions such as difficulty urinating or increased frequency, rectal discomfort or bleeding, changes in sexual function including erectile dysfunction. Acute toxicity may involve skin reactions in the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has a Gleason score of 7.
Select...
My prostate cancer was confirmed by a biopsy.
Select...
I can take care of myself and am up and about more than half of the day.
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I am 50 years old or older.
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My breast cancer is in an early stage according to my MRI results.
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My prostate is estimated to be 100 grams or less in size.
Select...
My cancer has not spread to other parts of my body according to recent tests.
Select...
My prostate symptoms are mild to moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My prostate cancer has spread to my lymph nodes or other parts of my body.
Select...
My cancer is at an advanced stage according to MRI results.
Select...
I have a history of Crohn's Disease or Ulcerative Colitis.
Select...
I have had surgery to remove part of my prostate.
Select...
I have had radiation therapy to my pelvic area before.
Select...
I have had surgery for prostate cancer.
Select...
My prostate cancer has a Gleason score above 7.
Select...
I have had major issues with urinating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants should be followed continuously for the duration of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants should be followed continuously for the duration of 5 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
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0
Secondary study objectives
Prostate-Specific Antigen
Pathological response based on biopsy at 24 months post-treatment
Quality of life assessment based on International Index of Erectile Function (IIEF)
+1 more

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IGRT 24 Gy single doseExperimental Treatment4 Interventions
single fraction IGRT at a prescription dose of 24 Gy
Group II: IGRT 45 Gy in 5 fractions of 9 GyActive Control4 Interventions
Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IGRT 45 Gy in 5 fractions of 9 Gy
2015
N/A
~30
IGRT 24 Gy single dose
2015
N/A
~30
Dexamethasone
FDA approved
Tamsulosin
FDA approved

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
296 Previous Clinical Trials
11,688,987 Total Patients Enrolled
2 Trials studying Prostate Cancer
59 Patients Enrolled for Prostate Cancer
Madhur Garg, MDPrincipal InvestigatorAssociate Clinical Director
3 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

IGRT 24 Gy single dose (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04147806 — Phase 2
Prostate Cancer Research Study Groups: IGRT 45 Gy in 5 fractions of 9 Gy, IGRT 24 Gy single dose
Prostate Cancer Clinical Trial 2023: IGRT 24 Gy single dose Highlights & Side Effects. Trial Name: NCT04147806 — Phase 2
IGRT 24 Gy single dose (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04147806 — Phase 2
~5 spots leftby Jul 2026
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