Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

NCT02723526 | Unknown

• 1 other identifier: CTC-mHSPC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.

Conditions

Prostate Cancer

Keywords

Metastatic Hormone-Sensitive Prostate Cancer；circulating tumor cells；Prognosis；Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• time to castration-resistant prostate cancer

  3 years

Secondary Outcomes (4)

• time to radiographic progression

  3 years

• time to prostate specific antigen (PSA) progression

  3 years

• time to prostate specific antigen (PSA) nadir

  2 years

• complete serologic response rate at 6 month and 12 month

  1 years

Study Arms (1)

Single arm

Other: Blood drawing

Interventions

Blood drawing OTHER

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer

You may qualify if:

• Male patients;
• yrs and older, and 80 yrs and younger;
• Histologically or cytologically proven prostate adenocarcinoma;
• Imaging examinations including Emission Computed Tomography (ECT),Positron Emission Tomography (PET),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
• Not yet receiving hormonal therapy;
• Not yet receiving chemotherapy previously;
• Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
• Patients are willing to participate and can be followed up regularly；

You may not qualify if:

• Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
• Patients received chemotherapy previously;
• Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

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)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bo Dai, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Dai, MD

CONTACT

+86-21 64175590; bodai1978@126.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Department of Urology

Study Record Dates

• First Submitted: March 26, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)