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Radiation Therapy
Hypofractionated Radiation Therapy for Prostate Cancer
Phase 1
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status 0-1
Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 120 days prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after completion of treatment, every 3 months for year 1, and every 6 months during year 2
Awards & highlights
Study Summary
This trial is testing if it is safe to give three different schedules of radiation therapy to the pelvis and prostate to see if it kills cancer cells while not harming normal cells too much.
Who is the study for?
Men over 18 with intermediate to high-risk prostate cancer, without bone metastases or previous chemotherapy for prostate cancer. They must have a good performance status and be able to consent. Excluded are those with prior pelvic radiation, certain blood thinners, autoimmune diseases that could worsen with radiation, or any severe condition that might complicate participation.Check my eligibility
What is being tested?
This phase I trial tests the safety of three different schedules of Hypofractionated Radiation Therapy targeting the pelvic lymph nodes and prostate. The therapy aims to increase the dose to the cancer while keeping it safe for normal tissues.See study design
What are the potential side effects?
Potential side effects may include skin reactions in treated areas, fatigue, gastrointestinal issues like diarrhea or discomfort, urinary problems such as increased frequency or urgency, and possibly inflammation in nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My recent scans showed no signs of cancer in my lymph nodes.
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I have prostate cancer that needs radiation treatment for both the prostate and pelvic area.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after completion of treatment, every 3 months for year 1, and every 6 months during year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after completion of treatment, every 3 months for year 1, and every 6 months during year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT
Secondary outcome measures
Dose volume histogram (DVH) parameters
Evaluate the duration of biochemical progression-free survival
Acute Coryza
+2 moreSide effects data
From 2022 Phase 2 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Level 3Experimental Treatment1 Intervention
Dose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 12 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
Group II: Dose Level 2Experimental Treatment1 Intervention
Dose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 16 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
Group III: Dose Level 1Experimental Treatment1 Intervention
Dose schedules were calculated to maintain similar BED for late normal tissue injury (α/β= 3.0 Gy), with an increased BED for PC (α/β= 1.5Gy). Patients be treated with 20 fractions. A total of 6 patients will be treated at the dose that is determined to be Maximum Tolerated Dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,638 Total Patients Enrolled
12 Trials studying Prostate Cancer
581 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My recent scans show no cancer spread to bones.I am scheduled for a targeted radiation treatment for my prostate.My bone scan was unclear, but my X-rays (or CT/MRI) showed no signs of cancer spread.I have had surgery or specific treatments for prostate cancer.My recent scans showed no signs of cancer in my lymph nodes.My prostate cancer was confirmed by a lab test within the last 6 months.I do not have an autoimmune disease that my doctor thinks would make pelvic radiation unsafe for me.I am on a full-dose blood thinner or taking clopidogrel.I have prostate cancer that needs radiation treatment for both the prostate and pelvic area.I am 18 years old or older.My cancer has spread to distant parts of my body.My cancer has spread to nearby lymph nodes.I am currently taking 81 mg of Aspirin daily.I have had chemotherapy for prostate cancer.My lymph nodes are questionable but smaller than 1.5 cm.I've had a recent physical exam, including checks on my prostate, bones, and abdomen.I have had radiation treatment to my pelvis or seed implant therapy in my prostate.I have had ulcers in my small intestine before.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 3
- Group 2: Dose Level 1
- Group 3: Dose Level 2
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.
To what magnitude is the current participant pool of this trial?
"Affirmative, clinicaltrials.gov records indicate that this trial has been actively recruiting since November 19th 2020 and is currently in search of 18 patients to be enrolled at 1 medical centre."
Answered by AI
Is Hypofractionated Radiation Therapy a reliable approach for ensuring safety?
"As this is an initial stage trial, the safety of Hypofractionated Radiation Therapy was scored a 1 due to limited clinical data indicating its efficacy and safety."
Answered by AI
Is the recruitment process for this research endeavor still ongoing?
"Per clinicaltrials.gov, the researchers are actively seeking participants for this experiment, which was posted on November 19th 2020 and most recently updated April 26th 2022."
Answered by AI
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