Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTP… (NCT04616547) | Clinical Trial Compass
TerminatedPhase 2
Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTPA) in Patients With Prostate Cancer That Has Spread to Bones
Stopped: Insufficient drug supply
United States1 participantsStarted 2021-12-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that is castration-resistant, defined as:
* A castrate serum testosterone level =\< 50 ng/dL or 1.7 nmol/L
* Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH). Androgen deprivation therapy needs to be maintained throughout the study unless a patient has had orchiectomy by surgery
* Serum PSA progression defined as two consecutive increases in PSA over a previous reference value, each measurement at least 1 week apart
* Progression after androgen receptor blockers (enzalutamide, apalutamide, or darolutamide) or androgen synthesis blockers (abiraterone acetate) or chemotherapy (docetaxel or cabazitaxel). There are no maximum number of prior therapies
* Progressive castration-resistant prostate cancer with two or more skeletal metastases identified by Tc-99m bone scintigraphy or prostate specific membrane antigen (PSMA) positron emission tomography (PET) scan
* Patients must have self-reported moderate to severe pain at trial entry (baseline weekly average "worst pain in the past 24-hours" scores of \>= 4 on an 11-point numeric rating scale \[NRS\], the Brief Pain Inventory - Short Form \[BPI-SF\] item #3 for worst pain)
* Patients must either currently employ regular (not occasional) analgesic medication use for cancer-related bone pain or have undergone treatment with external beam radiation …