Clonal Emergence and Regression During Radium-223 Therapy for Metastatic Prostate Cancer

NCT03677076 | Completed DMC

• 2 other identifiers: 102691IIR-US-2017-4183
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with metastatic prostate cancer receiving radium-223 as their standard of care therapy. The researchers will collect blood and urine samples from patients before, during and after the radium-223 therapy. The researchers will compare these samples to observe how the treatment has affected different cancer markers.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Minor allele frequency (MAF) in ctDNA

  The primary objective is to estimate average change in MAF in one or more clonal SNVs, comparing baseline to on-treatment, and baseline to post-treatment samples

  24 months

Secondary Outcomes (5)

• Changes in MAF of clonal SNV

  24 months

• Change in clonal mutation MAF and change in pain

  24 months

• Change in clonal mutation MAF and change in tumor markers

  24 months

• Change in clonal mutation MAF and markers of bone metabolism

  24 months

• Change in clonal mutation MAF and presence of the TMPRSS2-ERG fusion gene

  24 months

Study Arms (1)

Ancillary/Correlative

Patients will complete questionnaires and have research blood drawn.

Other: Ancillary/Correlative

Interventions

Ancillary/Correlative OTHER

Collection of research blood and urine

Ancillary/Correlative

Eligibility Criteria

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

Study Population

adult males with prostate cancer receiving radium223 treatment

You may qualify if:

• Prostate adenocarcinoma by history or medical records.
• Two or more bone metastases as demonstrated by imaging studies (technetium bone scan, fluoride PET scan, FDG PET scan, fluciclovine PET scan, CT scan, or MRI scan) or by biopsy.
• Patients must be on ADT with a GnRH receptor agonist/antagonist or orchiectomy, with or without an anti-androgen or testosterone synthesis inhibitor. Patients must have a documented castrate level of testosterone (\<50ng/dL) and be willing to continue their GnRH agonist/antagonist during the course of radium-223 therapy.
• Patients may have had localized external beam radiation to as much as 20% of the skeleton
• Adequate hematopoietic, renal, and hepatic function. These parameters include:
• Hemoglobin ≥ 10gm/dL
• WBC ≥ 3.0K/mcL
• ANC ≥ 1.5K/mcL
• Platelet count ≥ 100K/mcL
• Creatinine \< 1.5 ng/mL
• Total bilirubin \<1.5 ng/mL.
• Albumin \> 25 g/L
• Patients should have an elevated, relevant tumor marker such as PSA, CEA, or LDH.
• Age ≥18 years old
• Life expectancy of at least 24 weeks

You may not qualify if:

• Initiation of any additional anti-tumor therapy within 2 months of starting radium-223 treatment
• Presence of only lytic bone metastases
• Prior cytotoxic chemotherapy for metastatic PCa
• Prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases
• Other malignancy requiring systemic therapy within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
• Visceral (i.e. liver, lung, brain, adrenal, brain, but not lymph node) metastases as assessed by chest, abdominal, or pelvic computed tomography, or other imaging modality)
• Lymphadenopathy exceeding 6 cm in short-axis diameter, or any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
• Imminent spinal cord compression based on clinical findings and/or MRI. Treatment should be completed for spinal cord compression.
• Any infection ≥ Grade 2 per NCI-CTCAE version 5.0
• Cardiac failure NYHA III or IV
• Crohn's disease or ulcerative colitis
• Bone marrow dysplasia, myelodysplasia
• Fecal incontinence
• Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: March 4, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)