AzTrials
AzTrials

Prostate CancerNCT02432001

Radiologically Guided Biopsies of mCRPC

An observational study of Prostate Cancer, run by University of California, San Francisco at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to better understand how cancer treatment may affect cancer cells. The research will involve genetic, molecular, cellular, and immunologic experiments using blood and tumor specimens. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Image-Guided Biopsies
Type of treatment
Surgery or procedure
How many people
256 participants
Where
5 sitesin 2 countries
Study dates
22 Feb 2013to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Prostate Cancer

Who may be able to join

  • History of histologically confirmed prostate cancer. Patients without histologically confirmed prostate cancer are eligible if both the treating physician and the study investigator agree that the patient's history is unambiguously indicative of advanced prostate cancer (e.g. high PSA responsive to Androgen Deprivation Therapy.)
  • Radiographic evidence of metastatic disease amenable to image-guided biopsy of a metastatic site. Soft-tissue as well as bony metastatic lesions will be considered acceptable. Patients with locally advanced disease only (where the biopsy would be of a prostatic mass) are not eligible. Biopsy of newly emerging radiographic metastases is desired and preferable to the biopsy of previously existing lesions whenever possible.
  • Platelets >75,000/μl within 14 days prior to biopsy
  • Prothrombin time (PT) or International Normalized Ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
  • Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the PI.
  • Castrate levels of testosterone (testosterone <50n g/dL) within 28 days prior to biopsy.
Show all 25Show fewer
  • Patients with significant congenital or acquired bleeding disorders (eg von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible.
  • If no prior orchiectomy, medical castration therapy must continue while on study.
  • Prostate-specific antigen (PSA) level obtained within 28 days prior to biopsy.
  • Patients currently on first generation oral anti-androgens (flutamide, bicalutamide, nilutamide) must have progressed after at least 4 weeks of anti-androgen discontinuation.
  • Patient's disease is currently progressing (in setting of testosterone < 50 ng/dl), defined by any of the following criteria:
  • PSA Progression: PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart. If the confirmatory PSA (#3) value is less (i.e., #3b) than the screening PSA (#2) value, then an additional test for rising PSA (#4) will be required to document progression for the purposes of eligibility.
  • Soft tissue progression: by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Bone scan progression: the appearance of >=2 new lesions. Symptomatic progression in an area of radiologically evident disease.
  • One of the following criteria must be met:
  • Evidence of disease progression (as defined above) following treatment with at least 2 months of abiraterone acetate, enzalutamide, or ARN509 - based therapy.
  • Enrollment on a high priority clinical trial conducted by the West Coast Dream Team (WCDT). Examples include trials with biopsy obtained before abiraterone or enzalutamide therapy, and following development of resistance to those agent(s). This list is maintained by the lead site.
  • Evidence of disease progression (as defined above) in patients with "aggressive phenotype" metastatic castration resistant prostate cancer (mCRPC) with at least one of the following clinical features
  • Visceral or brain metastases
  • Known small cell or neuro-endocrine subtypes (by Immunohistochemistry (IHC) or serum markers)
  • Primary androgen deprivation therapy (ADT) resistance defined as a nadir PSA of > 4 ng/dl after 7 months of primary androgen deprivation (with Testosterone < 50 ng/dl.)
  • Prior chemotherapy for Castration Resistant Prostate Cancer is not allowed
  • Age > 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-3
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

None listed.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • University of California, Davis

    Davis, California, 95616

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California

    San Francisco, California, 94143

Other trials in United States

Canada1 site

  • University of British Columbia

    Vancouver

Other trials in Canada

About this study

Official title: Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer (mCRPC) to Identify Adaptive Mechanisms of Resistance

The purpose of this study is to better understand how cancer treatment may affect cancer cells. The research will involve genetic, molecular, cellular, and immunologic experiments using blood and tumor specimens. It is hoped that the information gained from these studies will lead to a greater understanding of castrate-resistant prostate cancer and potentially, improvements in cancer treatment.

This is a tissue collection protocol requiring image-guided biopsies of metastatic, castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling patients with metastatic CRPC who have progressed while receiving novel AR-targeted therapeutics such as abiraterone and enzalutamide. This population of patients was selected because resistance develops relatively rapidly following potent inhibitors of AR activity and the mechanisms of resistance have to be better understood. Without comprehensive analysis of mCRPC tumor, the investigators will never gain a full understanding of the biology driving resistance in human disease and developing rational co-targeting approaches will not be possible.

Conditions
Prostate Cancer
Being tested
Image-Guided Biopsies
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Image-Guided BiopsiesProcedure or surgery

Study groups in NCT02432001
Study groupRoleWhat they receive
Image-Guided BiopsiesImage-guided biopsies will be performed at the Dream Team Site enrolling the patient. Lesions will be chosen based upon the strength of the evidence suggesting the presence of metastasis and with the goal of minimizing patient risk. Soft tissue lesions and lesions with documented radiologic progression should be prioritized for biopsy. If the Radiologist in charge of the procedure cannot identify a lesion amenable for biopsy, the patient will be considered a screening failure.
Receives: Procedure: Image-Guided Biopsies

What is being measured

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

  1. Proportion of mCRPC patients with high androgen receptor activity

    Determined by a gene-expression-based signature for Androgen Receptor activity having a probability of >0.50

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Progression Free Survival

    Measured from the start of therapy after the baseline biopsy until progression. Patients not progressing will be censored at the date of last clinical follow-up or date of last contact, respectively.

    Measured: Up to 2 years

  2. Overall Survival

    Measured from the start of therapy after the baseline biopsy until death. Patients not progressing or dying will be censored at the date of last clinical follow-up or date of last contact, respectively

    Measured: Up to 2 years

Timeline

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

  1. First posted1 May 2015 (estimated)
  2. Study start22 Feb 2013
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02432001
Sponsor's protocol ID
125519
Status last verified
Oct 2021
First submitted
28 Apr 2015
Last updated
8 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aggarwal R, Huang J, Alumkal JJ, Zhang L, Feng FY, Thomas GV, Weinstein AS, Friedl V, Zhang C, Witte ON, Lloyd P, Gleave M, Evans CP, Youngren J, Beer TM, Rettig M, Wong CK, True L, Foye A, Playdle D, Ryan CJ, Lara P, Chi KN, Uzunangelov V, Sokolov A, Newton Y, Beltran H, Demichelis F, Rubin MA, Stuart JM, Small EJ. Clinical and Genomic Characterization of Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer: A Multi-institutional Prospective Study. J Clin Oncol. 2018 Aug 20;36(24):2492-2503. doi: 10.1200/JCO.2017.77.6880. Epub 2018 Jul 9.

    PubMed 29985747

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by University of California, San Francisco at 5 sites in 2 countries.

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 25 inclusion and 0 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: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of mCRPC patients with high androgen receptor activity (time frame: Up to 2 years). 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 NCT02432001, 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 8 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in