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Radioactive Agent
SBRT + Radium-223 for Prostate Cancer
Phase 2
Recruiting
Led By Michael Zelefsky, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Creatinine ≤ 1.5 x ULN with normal creatinine clearance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether adding the study drug Radium-223 chloride to standard SBRT treatment helps people with prostate cancer that has spread to the bones.
Who is the study for?
Men over 18 with prostate cancer that has spread to bones (1-3 sites) and treated primary tumor. They must have a PSA level of 0.5-50 ng/mL, good performance status, normal organ function, and agree to contraception if needed. Excluded are those with certain prostate cancer types, more than three bone metastases, brain metastases or other serious conditions.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining Stereotactic Body Radiation Therapy (SBRT) with Radium (Ra-223) dichloride versus SBRT alone in treating prostate cancer that has spread to the bones.See study design
What are the potential side effects?
Potential side effects may include radiation-related issues such as fatigue, skin reactions at treatment site, gastrointestinal symptoms like nausea or diarrhea; radium Ra-223 could cause blood cell count changes leading to anemia or increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My kidney function tests are within normal limits.
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My prostate cancer was confirmed through a biopsy.
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My prostate cancer was treated with surgery or radiation.
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My scans show 1-3 bone metastases, confirmed by a recent PSMA PET scan.
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I am 18 years old or older.
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My bone metastases can be treated with a specific type of targeted radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment1 Intervention
Participants will receive two cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks followed 2-3 weeks later by SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease. SBRT to the target index lesion(s) should be completed within 30 days after simulation after completion of the 2nd infusion of Radium (Ra-223) dichloride. Specific dose constraints, dosing schedules, and management of SBRT to multiple sites will be at the discretion of the treating Radiation oncologist. The goal is to complete simulation and SBRT within 30 days. Only active or progressive disease is to be treated at the discretion of the treating investigator.
Group II: Control Arm:Active Control2 Interventions
Participants will receive SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease. SBRT fractions can be administered every day or every other day per institutional practice. SBRT should begin within 30 days (+/- 7 days) of randomization. Only active or progressive disease is to be treated at the discretion of the treating investigator.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,745 Total Patients Enrolled
132 Trials studying Prostate Cancer
51,938 Patients Enrolled for Prostate Cancer
Michael Zelefsky, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
906 Total Patients Enrolled
8 Trials studying Prostate Cancer
599 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I have not had any cancer in the past 3 years, except for treated skin cancer.My kidney function tests are within normal limits.I do not have any serious illness or infections worse than a mild condition.I am willing and able to follow the study's requirements.I experience loss of bowel control.I have had hormone therapy for cancer but my testosterone is now normal, or I've never had hormone therapy and my testosterone is low.I am a man who has had radiotherapy for prostate cancer and my testosterone levels are now normal.I agree to use condoms and my partner will use effective birth control during and 6 months after my treatment.I have not had treatment with radioactive drugs for bone cancer spread.My prostate cancer was confirmed through a biopsy.I have or might soon have severe spinal cord compression.My prostate cancer was treated with surgery or radiation.I haven't taken any experimental cancer treatments in the last 4 weeks.My scans show more than 3 separate areas of cancer spread.My scans show 1-3 bone metastases, confirmed by a recent PSMA PET scan.I am 18 years old or older.My cancer has spread to the brain.I have a bone marrow disorder.I have Crohn's disease or ulcerative colitis.My bone metastases can be treated with a specific type of targeted radiation therapy.My prostate cancer is resistant to hormone therapy.My prostate cancer is of a specific type, like small cell or neuroendocrine.I have a cancer spread larger than 5 cm.My recent prostate MRI or biopsy was negative.My cancer has spread to lymph nodes outside the pelvis or to other organs.I have severe heart failure.I have not had major surgery in the last 30 days.My cancer in the lymph nodes is getting worse, but I've had surgery or radiation with no progression.My blood, liver, and kidney functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
- Group 2: Control Arm:
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.
How many different medical facilities are coordinating this trial?
"Memorial Sloan Kettering Commack (Limited Protocol Activities), Memorial Sloan Kettering Bergen (Limited Protocol Activities), and Memoral Sloan Kettering Monmouth (Limited Protocol Activities) are three of the nine locations currently recruiting patients for this clinical trial."
Answered by AI
Has Radium dichloride received FDA approval for therapeutic use?
"Radium dichloride only has data supporting its safety, and no evidence of efficacy. Consequently, it was given a score of 2."
Answered by AI
Are there any unfilled positions in this clinical trial for test subjects?
"That is correct, the trial hosted on clinicaltrials.gov is still admitting patients. 9 different centres are participating in the study and they aim to enroll 136 individuals in total. The trial was originally posted on November 12th, 2021 and updated September 15th, 2022."
Answered by AI
How many individuals are being monitored in this clinical research?
"In order to commence this clinical trial, 136 participants that meet the pre-specified inclusion criteria are required. These patients can enroll at various Memorial Sloan Kettering locations such as Commack, New jersey and Montvale, Colorado."
Answered by AI
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