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Castration-Resistant Prostate CarcinomaPhase 2NCT04616547

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

A Phase 2 study testing Questionnaire Administration and Tin Sn 117m Pentetate in people with Castration-Resistant Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Questionnaire Administration and Tin Sn 117m Pentetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
18 Dec 2021to 11 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Total bilirubin =< 2.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 5 x institutional ULN
  • Creatinine =< 1.7 mg/dL OR glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2
  • Patients receiving bisphosphonates prior to enrollment can maintain bisphosphonate therapy throughout all or part of the study. The bisphosphonate may be stopped or started at the discretion of the investigator throughout the study (i.e., both treatment phase and follow-up). Injection of bisphosphonates should be done at least 2 hours before or after study drug administration
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • 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
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better
  • The effects of Sn-117m-DTPA on the developing human fetus are unknown. For this reason and because radionuclides are known to be teratogenic, male participants and their female partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of Sn-117m-DTPA administration
  • Patients must be willing and able to comply with the protocol and agree to return to the hospital for follow-up visits and examinations
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: A Single Arm Phase II Study of Bone-Targeted Sn-117m-DTPA in Symptomatic Castration Resistant Prostate Cancer With Skeletal Metastases

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of tin-117m diethylenetriaminepentaacetic acid (Sn-117m-DTPA) on sustained pain response in patients with castration-resistant prostate cancer (CRPC) metastatic to at least two bone sites with at least one clinically meaningful pain at baseline (>= 4 on an 11-point pain intensity scale).

SECONDARY OBJECTIVES:

  1. To assess the safety and tolerability of Sn-117m-DTPA per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

II. To measure Sn-117m-DTPA activity by gamma-camera dosimetry scans (serial full body planar images) obtained at 1 hour, 4 hours (or within 4-6 hours), 24 hours (or within 16-24 hours), 48 hours (or within 36-48 hours), 72 hours (or within 60-72 hours), 1 week (+/- 2 days), and 4 weeks (+/- 2 days) after the first Sn-117m-DTPA administration.

III. To evaluate the therapeutic efficacy of Sn-117m-DTPA at 24 weeks as measured by Prostate Cancer Working Group 3 (PCWG3) criteria.

IV. To evaluate time to the first symptomatic skeletal event defined as i) the first use of external-beam radiation therapy to relieve skeletal symptoms; ii) new symptomatic pathologic vertebral or nonvertebral bone fractures; iii) spinal cord compression; or iv) tumor-related orthopedic surgical intervention.

  1. To evaluate the overall pain response rate at 24 weeks. VI. To evaluate the duration of pain response defined as from the time of improvement in pain response (pain index =< 3) until the pain recurs.

VII. To measure changes and time to progression in serum prostate-specific antigen (PSA) and serum alkaline phosphatase (ALP) levels.

VIII. To measure patient-reported outcomes (PROs) and adverse events (AEs) (PRO-CTCAE) captured by digital instruments.

IX. To evaluate progression-free survival (PFS) and overall survival (OS).

EXPLORATORY OBJECTIVES:

  1. To examine any tumor genomic alterations that may be associated with response or resistance to Sn-117m-DTPA, a radiopharmaceutical agent.

II. To examine the changes in systemic inflammatory markers (such as interferon [IFN]-gamma, tumor necrosis factor [TNF]-alpha, interleukins [IL]-8, IL-10, and IL-17) by flow cytometry, and changes in markers of immune function by measuring the percentage and absolute number of CD4+ T helper cells, CD8+ T cytotoxic cells, T regulatory cells, polymorphonuclear (PMN) myeloid-derived suppressor cells (MDSCs), and mononuclear MDSCs (M-MDSCs) prior to treatment versus (vs.) end of cycle 1, end of cycle 2, and at week 24 and correlate values and/or changes with treatment outcomes.

III. To evaluate the feasibility of measuring polo-like kinase 1 (Plk1) expression via immunohistochemistry (IHC) staining on archival tissues.

OUTLINE:

Patients receive tin Sn 117m DTPA intravenously (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.

After completion of study, patients are followed up every 4 weeks until week 28, and then every 3 months for up to 12 months after the first dose of tin Sn 117m DTPA.

Being tested
Questionnaire Administration, Tin Sn 117m Pentetate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire AdministrationOther

    Ancillary studies

  • Tin Sn 117m PentetateRadiation

    Also called PENTETATE STANNIC SN-117M, Sn 117m Pentetic Acid, Sn-117m DTPA, Tin Sn 117m DTPA

    Given IV

Study groups in NCT04616547
Study groupRoleWhat they receive
Tin Sn 117m DTPAExperimentalPatients 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.
Receives: Other: Questionnaire Administration; Radiation: Tin Sn 117m Pentetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 16 weeks

Secondary outcomes (10)

  1. Incidence of Adverse Events (AEs)

    Safety and toxicity will be assessed through the frequency and percent of AEs, serious adverse events, and adverse events of special interests. Toxicity will be assessed using Common Terminology Criteria for Adverse Events. Will be assessed by patient reported outcomes (PROs) and AEs (PRO-Common Terminology Criteria for Adverse Events).

    Measured: Up to 6 months post-therapy

  2. Tin Sn 117m Diethylenetriaminepentaacetic Acid (DTPA) (Sn-117m-DTPA) Activity

    Gamma camera dosimetry will be used to evaluate whole-body distribution of Sn-117m-DTPA. Pearson's correlation coefficient method will be used to assess the correlation between the baseline technetium-99 bone scintigraphy measurement and the Sn-117m-DTPA uptake. If the observed data distribution is not appropriate to calculate the Pearson's correlation, post hoc analysis will be conducted using non-parametric methods or other methods suitable to the observed data distribution. The gamma dosimetry scan measurements will be reported descriptively as the average and standard deviation of dosimetry scan measurements and plotted over time and grouped by organ systems.

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

  3. Overall Response Rate

    A Fisher's exact 95% confidence interval will be calculated for the overall response rate. The denominator will include all patients who received at least one dose of study treatment and do not have major protocol deviations. Patients who do not have observed clinical response will be counted as negative responses.

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

  4. Time to First Symptomatic Skeletal Event

    The time from study enrollment to the first use of external-beam radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention will be evaluated. Will be analyzed using the Kaplan-Meier method. Estimation and confidence intervals for the median time to first symptomatic skeletal event will be provided.

    Measured: Up to 12 months

  5. Overall Pain Response Rate

    The rate of achievement of pain index =< 3 within 12 weeks from the first Sn-117m-DTPA will be evaluated.

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

  6. Duration of Pain Response

    Measured: Time from the achievement of pain response (pain index =< 3) to the recurrence of pain (pain index >= 4), assessed up to 16 weeks

  7. Prostate Specific Antigen (PSA) Response Rates

    Will be determined for the following benchmarks: >= 30% reduction of the blood level, compared to the baseline value; >= 50% reduction of the blood level, compared to the baseline value; confirmed PSA response: >=50% reduction of the blood level, compared to the baseline value, and confirmed by a second PSA value approximately 4 or more weeks later.

    Measured: Up to 28 weeks

  8. Alkaline Phosphatase (ALP) Response Rate

    Will be determined for the following benchmarks: >= 50% reduction of the blood level, compared to the baseline value; confirmed ALP response: >= 50% reduction of the blood level, compared to the baseline value, and confirmed by a second ALP value approximately 4 or more weeks later.

    Measured: Up to 28 weeks

  9. Clinical Progression-free Survival

    Defined as symptomatic progression (increasing pain from a metastatic lesion); progression of bone lesions assessed per Prostate Cancer Working Group 3 criteria; or progression of soft-tissue lesions assessed per Response Evaluation Criteria in Solid Tumors version 1.1 criteria. PSA progression without progression on bone lesions nor symptomatic is not considered as clinical progression. Will be summarized by Kaplan-Meier methods.

    Measured: Time of study enrollment until disease progression, assessed up to 12 months

  10. Overall Survival

    Will be summarized by Kaplan-Meier methods.

    Measured: Time of the first study treatment until the date of death, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start18 Dec 2021
  3. Primary completion16 Feb 2022
  4. Study completion11 May 2022

Why it stopped: Insufficient drug supply

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616547
Sponsor's protocol ID
NCI-2020-08371
Other IDs
NCI-2020-08371, 10437, 10437, UM1CA186712
Status last verified
Sep 2025
First submitted
4 Nov 2020
Last updated
3 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • 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.

    PubMed 35428207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Questionnaire Administration and Tin Sn 117m Pentetate in people with Castration-Resistant Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Pain Response (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04616547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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