Bone-Targeted Radiation Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByZin W Myint

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies the effect of Sn-117m-DTPA on bone pain in patients with prostate cancer that has spread to the bones. Sn-117m-DTPA is a radioactive therapeutic agent that localizes to bones when given to patients. Sn-117m-DTPA may help reduce bone pain in patients with prostate cancer that has spread to the bones.

Eligibility Criteria

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.

Inclusion Criteria

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

My kidney function is normal or only slightly impaired.

My prostate cancer is resistant to hormone therapy.

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 take care of myself but might not be able to do heavy physical work.

I am 18 years old or older.

My cancer progressed after hormone therapy or chemotherapy.

My prostate cancer is worsening despite treatment and has spread to my bones.

My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

I have Crohn's disease or ulcerative colitis.

I do not have any infections that aren't responding to treatment.

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.

I have moderate to severe nerve damage affecting movement or sensation.

I do not have cancer spread to organs like the liver or lungs.

I do not have spinal cord compression.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Tin Sn 117m DTPAExperimental 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.