NCT01961843

Abiraterone Acetate for Castrate Resistant Prostate Cancer

Completed NA Last updated 25 November 2025

What this trial tests

NA trial testing Abiraterone in Prostate Cancer in 40 participants. Completed in 31 May 2024.

Timeline

14 January 2014

Primary endpoint
6 April 2023

31 May 2024

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	14 January 2014
Primary completion	6 April 2023
Estimated completion	31 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Abiraterone (ABIRATERONE) — full drug profile →
• Prednisone (prednisone) — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is a Pilot clinical trial. Pilot clinical trials often examine new tests (such as laboratory or radiology tests) in patients who receive either standard cancer treatments or new treatments that have been well-tested in many patients on other trials.

It is often difficult to determine how prostate cancer is going to behave when a new treatment is started. Physicians have no way to predict how a patient's tumor will respond to treatment. Although scientists have learned about changes that happen in tumors due to treatment, it is difficult to get cells from tumors because a biopsy (surgical procedure to remove a small piece of tissue) is needed.

This study will evaluate a method to detect tumor cells that are circulating in the blood without getting a biopsy. It is known that tumors shed a small number of cells into the blood stream every day. These are called circulating tumor cells or CTCs. Some early studies indicate the amount and type of CTCs in the blood can help determine the status of the tumor itself and the way it is responding to treatment. In this study, the investigators will examine protein levels in CTCs from patients' blood at different times before and after drug treatment to determine if they correlate with response to the drug. The new test will not affect whether subjects continue on the study drug.

Abiraterone acetate is a marketed drug that has been studied for the treatment of metastatic CRPC. It blocks the remaining or residual male hormones in the body that may be helping prostate cancer to grow. Abiraterone acetate is now FDA-approved for patients with metastatic CRPC who have not yet received docetaxel chemotherapy.

Abiraterone acetate has been used by a large number of participants in previous clinical trials. In most of these trials, participants with CRPC have been given abiraterone acetate with prednisone. Prednisone is a man-made hormone commonly referred to as a steroid. Prednisone has been approved in the US, Canada, and Europe for various disorders and diseases, such as asthma, Lupus and chronic obstructive lung disease. The combination of prednisone with abiraterone acetate has been approved for the treatment of CRPC. Prednisone together with abiraterone acetate will be given in this study in order to reduce or eliminate some side effects. Investigators will use patients' blood samples to study the genes (also called DNA) and their products (RNA and proteins) found in CTCs.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. An RNA-Based Digital Circulating Tumor Cell Signature Is Predictive of Drug Response and Early Dissemination in Prostate Cancer.
   Miyamoto DT, Lee RJ, Kalinich M, LiCausi JA, et al · · 2018 · cited 110× · PMID 29301747 · DOI 10.1158/2159-8290.cd-16-1406
2. Androgen receptor variant-driven prostate cancer II: advances in laboratory investigations.
   Lu C, Brown LC, Antonarakis ES, Armstrong AJ, et al · · 2020 · cited 35× · PMID 32139878 · DOI 10.1038/s41391-020-0217-3
3. Advancements in precision nanomedicine design targeting the anoikis-platelet interface of circulating tumor cells.
   Tang M, Zhang Z, Wang P, Zhao F, et al · · 2024 · cited 12× · PMID 39220884 · DOI 10.1016/j.apsb.2024.04.034