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Radioisotope Therapy
Bone-Targeted Radiation Therapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Zin W Myint
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Creatinine =< 1.7 mg/dL OR glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after the first dose of tin sn 117m dtpa
Awards & highlights
Study Summary
This trial is studying Sn-117m-DTPA to see if it can help reduce bone pain in patients with prostate cancer that has spread to the bones.
Who is the study for?
Men with prostate cancer that has spread to bones, resistant to castration treatment, and experiencing moderate to severe bone pain. They must have a low testosterone level due to medication or surgery, rising PSA levels despite therapy, and at least two bone metastases confirmed by scans. Participants need proper liver function, controlled HIV or hepatitis if present, no major heart issues (class 2B or better), an ECOG status of <=2 (able to do light work), adequate blood counts and kidney function. Men must agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing Sn-117m-DTPA's effectiveness in reducing bone pain for men whose prostate cancer has spread there. It involves administering this radioactive therapeutic agent which targets bones specifically. The study will monitor changes in patients' reported pain levels after receiving the treatment.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with radiation therapies such as fatigue, nausea, skin irritation at injection sites, and possible allergic reactions specific to Sn-117m-DTPA components. There may also be risks related to radioactivity exposure like temporary hair loss or blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My kidney function is normal or only slightly impaired.
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My prostate cancer is resistant to hormone therapy.
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I experience moderate to severe pain, rating it 4 or higher out of 11.
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I am on hormone therapy for cancer or have had surgery to remove my testicles.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My cancer progressed after hormone therapy or chemotherapy.
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My prostate cancer is worsening despite treatment and has spread to my bones.
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My hepatitis B virus load is undetectable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months after the first dose of tin sn 117m dtpa
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after the first dose of tin sn 117m dtpa
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sustained pain response
Secondary outcome measures
Alkaline phosphatase (ALP) response rate
Clinical progression-free survival
Pain
+7 moreOther outcome measures
Changes in systemic inflammatory markers and immune cell populations
Polo-like kinase 1 immunohistochemistry
Tumor genomic alterations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (tin Sn 117m DTPA)Experimental Treatment2 Interventions
Patients receive tin Sn 117m DTPA IV over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression.
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,152 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Zin W MyintPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had hepatitis C but am cured, or I'm being treated with no detectable virus.I do not have any severe illnesses that are not under control.I regularly use pain medication for cancer-related bone pain or had radiation therapy for bone pain within the last 4 weeks.I have another cancer type, but it won't affect this trial's treatment.You have never had an allergic reaction to substances similar to Sn-117m-DTPA.I haven't had any bone fractures in the last 2 months.I have Crohn's disease or ulcerative colitis.My kidney function is normal or only slightly impaired.My prostate cancer is resistant to hormone therapy.I agree to use effective birth control during and 6 months after the study.I do not have any infections that aren't responding to treatment.I experience moderate to severe pain, rating it 4 or higher out of 11.I am on hormone therapy for cancer or have had surgery to remove my testicles.I can continue my bisphosphonate therapy during the study.My cancer has not spread to lymph nodes larger than 3 cm.I haven't had certain bone-targeted radiotherapies in the last 24 weeks.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I am HIV positive, on treatment, and my viral load is undetectable.My cancer progressed after hormone therapy or chemotherapy.I have moderate to severe nerve damage affecting movement or sensation.I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 4 weeks.I have recovered from side effects of previous cancer treatments, except for hair loss.I do not have cancer spread to organs like the liver or lungs.My prostate cancer is worsening despite treatment and has spread to my bones.I do not have spinal cord compression.My hepatitis B virus load is undetectable with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (tin Sn 117m DTPA)
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.
Are there any harmful side effects associated with Tin Sn 117m DTPA?
"Tin Sn 117m DTPA is a safe medication, as evidenced by its Phase 2 clinical trial status. However, there is no data currently supporting its efficacy."
Answered by AI
Are there any open slots for participants in this experiment?
"This particular trial, which was first advertised on December 9th 2021, is no longer recruiting patients. Although this specific study is not open for enrollment, there are 3690 other trials that currently have open recruitment statuses."
Answered by AI
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