Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223

NCT02981797 | Completed

• 2 other identifiers: MCC-17725ONC-2013-067
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as standard of care. Participants will take part in this research study because they have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Investigators want to find out if a blood test performed before and after the Radium 223 treatment will help to understand how prostate cancer cells react to this therapy. In this pilot study, researchers want to find out if Radium 223 given as part of standard treatment for prostate cancer can decrease the number of circulating prostate cancer cells. Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the changes in the number of circulating prostate cancer cells before and after Radium 223, researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX, in the circulating prostate cancer cells before and after treatment with Radium 223. Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same tube of blood that is used for assessing the changes in the number of circulating prostate cancer cells.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

symptomatic bone metastasis; metastatic; castration resistant

Outcome Measures

Primary Outcomes (2)

• Changes in Gamma H2AX Positivity

  Assess changes in gamma H2AX positivity in circulating prostate cancer cells before and after Radium 223 treatment. CTC numeration, the gamma-H2AX detection and interpretation will be performed by Veridex with the cell search platform.

  24 weeks per participant

• Changes in Circulating Prostate Cancer Cell Numbers

  Assess changes in circulating prostate cancer cell numbers before and after Radium 223 treatment. CTC numeration, the gamma-H2AX detection and interpretation will be performed by Veridex with the cell search platform.

  24 weeks per participant

Secondary Outcomes (3)

• Pain Response

  Up to 24 weeks

• Changes in Narcotic Analgesic Use

  Up to 24 weeks

• PSA Response

  At week 12

Other Outcomes (2)

• Bone Scan Response

  Up to 24 weeks

• Changes in Alkaline Phosphatase

  Up to 24 weeks

Study Arms (1)

Radium 223 Standard of Care

Standard of Care and Blood Collection for Baseline Circulating Tumor Cells (CTCs) Numeration and H2AX Assay. Participants who have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Week 1 starts with the first Radium 223 treatment and week 24 ends 4 weeks after the last or sixth Radium 223 treatment. The circulating prostate cancer cell analysis will be performed within 24 hours of blood draw. Any unused blood samples for circulating prostate cancer cell analysis will be disposed per lab protocol.

Other: Blood Collection During Standard of Care Treatment

Interventions

Blood Collection During Standard of Care Treatment OTHER

Blood collection for baseline CTC numeration and H2AX assay. Circulating prostate cancer cell analysis requires blood draw of 7.5 ml (about 1 ½ teaspoons) of blood, to be performed at the screening, 1-2 hours before the third and sixth dose of radium 223 and 24 hours after the first, third, sixth dose of Radium 223. Standard of care Radium 223 treatment is given every 4 weeks for a total of 6 treatments and post Radium 223 follow up at week 24 is also considered standard of care. Other than these standard clinic visits and treatments, the study only requires 3 extra trips to the cancer center for blood draw at 24 hours after the first, third, sixth dose of Radium 223. Blood draws other than circulating tumor cell analysis is considered standard of care and doesn't require extra visits.

Radium 223 Standard of Care

Eligibility Criteria

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

Study Population

Participants who have chosen Radium 223 treatment as Standard of Care, for their prostate cancer that has spread to the bone and causing pain.

You may qualify if:

• Male patients 18 years or older
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Receiving radium 223 as standard of care for symptomatic metastatic castration resistant prostate cancer to the bone as documented by bone scan or Sodium Fluoride positron emission tomography (PET) bone scan.
• No evidence of visceral metastasis
• Prior surgical castration or concurrent use of GnRH analogue (i.e., medical castration) with testosterone at screening \<50 ng/dL.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2, ECOG 3 is allowed if due to pain
• Adequate organ function: Serum alanine aminotransferase (ALT) or aspirate aminotransferase (AST) must be \< 2.5 x upper limit of normal (ULN); Total bilirubin \< 1.5 s ULN; Estimated creatinine clearance must be \>40 mL/min; Absolute neutrophil count (ANC) \> 1500/l; Hemoglobin above 10 g/dl; platelet count \> 100,000/l.
• Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
• Life expectancy of 6 months or more
• Must agree to practice effective barrier contraception during the entire study treatment period \& through for 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
• Able to give written informed consent
• Have at least 2 CTCs at baseline

You may not qualify if:

• Exposure to radioisotope therapy (samarium 153, strontium 89) within 24 weeks or exposure to external beam radiation within 12 weeks of receiving the first dose of Radium 223
• Documented central nervous system metastases, has a history of seizure, stroke or transient ischemic attack (TIA)
• Treatment with any investigational compound within 30 days prior to the first dose of study drugs
• Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy \& have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• New York Association Class III or IV heart failure
• Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigators opinion, potentially interfere with participation in this study.
• Potential participants with delayed healing of wounds, ulcers, and/or bone fractures
• Inability to comply with protocol requirements

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Bayer: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jingsong Zhang, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  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: November 29, 2016
• First Posted: December 5, 2016
• Study Start: July 22, 2015
• Primary Completion: August 29, 2017
• Study Completion: November 5, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

US (1)