Study to Determine the Feasibility, Evaluability and Variability in Markers of Drug Action in Castration Resistant Prostate Cancer

NCT02424448 | Completed DMC

• 1 other identifier: CFTSp063 / 12_DOG04_145
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a biopsy feasibility study in which patients with castration resistant prostate cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and de novo), blood samples, a urine specimen and clinical data for research.

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Percentage of formalin fixed cancer tissue samples evaluable for immunohistochemical analysis

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Baseline levels of biomarkers in formalin fixed cancer tissue samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Intra-lesion temporal variability between formalin fixed cancer tissue samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Intra-lesion spatial variability between formalin fixed cancer tissue samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

Secondary Outcomes (4)

• Percentage of frozen cancer tissue samples evaluable for biomarker analysis

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Baseline levels of biomarkers in frozen cancer tissue samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Intra-lesion temporal variability between frozen cancer tissue samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Intra-lesion spatial variability between frozen cancer tissue samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

Other Outcomes (2)

• Intra-patient, inter-lesion variability (where possible) between samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

• Percentage concordance between biomarker measurements on circulating tumour cells (CTCs) and tumour samples

  Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)

Study Arms (1)

Metastatic CRPC

Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy. Patients will have biopsies, blood and urine samples taken.

Procedure: Biopsies, blood and urine samples

Interventions

Biopsies, blood and urine samples PROCEDURE

Session 1: Biopsies will be taken from the main study lesion and up to 2 metastatic sites at 1 visit or over 3 visits. Both formalin fixed and snap frozen material will be collected. At the session (i.e. once over the potential maximum of 3 visits in a session) a urine sample, blood samples for circulating tumour cells (CTC) and an exploratory blood sample (processed to plasma) will be taken. Session 2: 7 days +/-3 following the last biopsy taken from Session 1, repeat biopsies from the same tumour sites will be obtained. In cases where this is not possible, it is acceptable to biopsy alternative lesions. As in Session 1 biopsies may be taken at 1 visit or over 3 visits and urine, CTC blood samples and an exploratory blood sample (processed to plasma) will be taken.

Metastatic CRPC

Eligibility Criteria

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

Study Population

Males (18+) with metastatic hormone refractory prostate cancer

You may qualify if:

• Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy
• Patients aged 18 years and older
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
• Provision of archival tumour sample for PTEN status determination as directs group assignment
• Provision of written informed consent
• Provision of cancer tissue samples, willing to undergo 1-3 biopsies on 2 separate occasions
• No change of cancer treatment anticipated until final biopsy/ blood samples have been taken
• Serum testosterone level \<50 ng/dL sustained by medical or surgical castration

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Previous enrolment in the present study
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
• Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
• Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection
• Radiotherapy to lesion to be biopsied within 4 weeks of biopsy
• Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
• Patients at increased risk of bleeding as a result of biopsy
• History of bleeding disorders or thrombocytopenia (platelets \<100)
• Concomitant treatment with anticoagulant therapy such as warfarin/low molecular weight heparin (Aspirin not contra-indicated but consider temporary cessation if biopsy site has higher risk of bleeding e.g. liver)
• Current urinary tract infection (UTI) or prostatitis
• Known infection with HIV, Hepatitis B or Hepatitis C

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• AstraZeneca: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Original diagnostic tumour blocks will be returned at the end of the study. Biopsy samples taken will either be retained or disposed of when the study is completed.

MeSH Terms

Interventions

Biopsy; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tony Elliott

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trials Project Manager

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 23, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

GB (1)