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

NCT04616547 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: NCI-2020-0837110437UM1CA186712
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Castration-Resistant Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Sustained Pain Response

  Defined as achieving pain index =\< 3 within a 12-week period, maintaining that pain index =\< 3 over a 16-week time period. Will also be summarized by the point estimation of the overall response rate (ORR) with the corresponding 95% confidence intervals. Patients who received any amount of study drug will be included in the denominator for the calculation of ORR.

  Baseline to 16 weeks

Secondary Outcomes (10)

• Incidence of Adverse Events (AEs)

  Up to 6 months post-therapy

• Tin Sn 117m Diethylenetriaminepentaacetic Acid (DTPA) (Sn-117m-DTPA) Activity

  Up to 4 weeks after the first Sn-117m-DTPA administration

• Overall Response Rate

  Up to 12 months after the first dose of tin Sn 117m DTPA

• Time to First Symptomatic Skeletal Event

  Up to 12 months

• Overall Pain Response Rate

  Within 12 weeks from first dose of Sn-117m-DTPA

Other Outcomes (3)

• Tumor Genomic Alterations

  Up to 12 months

• Changes in Systemic Inflammatory Markers and Immune Cell Populations

  Baseline to after completion of treatment

• Polo-like Kinase 1 Immunohistochemistry

  Up to 12 months

Study Arms (1)

Tin Sn 117m DTPA

EXPERIMENTAL

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.

Other: Questionnaire Administration; Radiation: Tin Sn 117m Pentetate

Interventions

Questionnaire Administration OTHER

Ancillary studies

Tin Sn 117m DTPA

Tin Sn 117m Pentetate RADIATION

Given IV

Also known as: PENTETATE STANNIC SN-117M, Sn 117m Pentetic Acid, Sn-117m DTPA, Tin Sn 117m DTPA

Tin Sn 117m DTPA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 therapy (EBRT) for bone pain within 4 weeks before starting study treatment
• Age \>= 18 years. Children \< 18 years of age are excluded from the study as the prevalence of prostate cancer is extremely rare in this age group
• Patients must have a life expectancy \>= 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
• Patients must have a serum PSA value \>= 1 ng/mL
• Absolute neutrophil count \>= 1,000/mcL
• Platelets \>= 100,000/mcL
• Hemoglobin \> 10.0 g/dL

You may not qualify if:

• Patients must not have visceral metastases (such as liver and lung) as assessed by abdominal/pelvic computed tomography (CT) or chest X-ray within 12 weeks before starting study treatment
• Patients must not have malignant lymphadenopathy exceeding 3 cm in short-axis diameter
• Patients must not have imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
• Patients who have had chemotherapy, immunotherapy, or external radiotherapy within 4 weeks prior to entering the study
• Patients must not have received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186, or rhenium-188 for the treatment of bony metastases within 24 weeks before starting study treatment
• Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
• Patients must not have received any investigational agents within 4 weeks before starting study treatment, nor be scheduled to receive one during the planned treatment period
• Patients must not have unmanageable urinary incontinence
• Patients must not have had known non-pathological bone fractures within 2 months before starting study treatment
• Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sn-117m-DTPA
• Patients must not have uncontrolled intercurrent illness, including:
• Any uncontrolled infection
• Grade 2 or greater motor or sensory neuropathy
• Crohn's disease or ulcerative colitis
• Patients with psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• Myint ZW, El Khouli R, Lemieux B, Yan D, St Clair WH, Liu X, Kunos CA. A single arm phase II study of bone-targeted Sn-117 m-DTPA in symptomatic castration-resistant prostate cancer with skeletal metastases. BMC Cancer. 2022 Apr 15;22(1):415. doi: 10.1186/s12885-022-09496-2.

  PMID: 35428207 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pentetic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Zin Myint
• Organization: Markey Cancer Center

zin.myint@uky.edu

866-340-4488

Study Officials

• Zin W Myint

  Ohio State University Comprehensive Cancer Center LAO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 5, 2020
• Study Start: December 18, 2021
• Primary Completion: February 16, 2022
• Study Completion: May 11, 2022
• Last Updated: October 3, 2025
• Results First Posted: April 16, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)