Study on Stereotactic Body Radiation Therapy and Radium (Ra-223) Dichloride for Prostate Cancer Spread to the Bones

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05133440

Provider View

This clinical trial is testing whether adding Radium (Ra-223) dichloride to standard radiation therapy can improve treatment for prostate cancer that has spread to the bones. Participants will receive either the combination treatment or standard radiation therapy alone.

Patient Parameters

Program Overview

The study aims to find out if combining Radium (Ra-223) dichloride with standard stereotactic body radiation therapy (SBRT) is more effective than SBRT alone in treating prostate cancer that has spread to the bones. Participants will be randomly assigned to receive either the combination treatment or just the standard SBRT.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer confirmed by biopsy.
  • Age 18 or older.
  • Previous treatment of the primary prostate tumor with surgery or radiotherapy.
  • Men who had additional radiotherapy to the prostate area or nearby lymph nodes can join if their testosterone levels are normal.
  • Recent MRI or biopsy shows no cancer in the prostate area.
  • Imaging shows 1-3 bone metastases within 60 days before joining the study.
  • All bone metastases must be suitable for a specific type of radiation therapy.
  • PSA levels between 0.5 and 50 ng/mL.
  • May have had hormone therapy before but must have normal testosterone levels now.
  • General health status allowing for daily activities with some restrictions.
  • Men with partners who can become pregnant must use condoms during and for 6 months after treatment. Female partners must use effective birth control during and for 6 months after treatment.
  • Adequate blood, liver, and kidney function as shown by specific lab tests.
  • Willing to follow study procedures and attend follow-up visits.

Exclusion Criteria

  • Prostate cancer with small cell or neuroendocrine features.
  • Any cancer spread larger than 5 cm.
  • Prostate cancer that no longer responds to hormone therapy.
  • More than 3 bone metastases shown by recent imaging.
  • Cancer spread to non-pelvic lymph nodes or other organs.
  • Enlarging lymph nodes in the pelvic area.
  • Risk of significant spinal cord compression.
  • Cancer spread to the brain.
  • Recent use of other experimental cancer treatments.
  • Major surgery within 30 days before starting the study.
  • Previous treatment with certain radioactive drugs for bone metastases.
  • Fecal incontinence.
  • History of another cancer within the last 3 years, except for certain skin cancers.
  • Serious illnesses or medical conditions, such as severe infections, advanced heart failure, inflammatory bowel disease, or bone marrow disorders.

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