- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543255
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial) (ACDC-RP)
January 30, 2024 updated by: University Health Network, Toronto
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC-RP Trial): A Randomized, Open-label, Multi-centre Phase-2 Study Evaluating the Pathological Complete Response (pCR) Rate Following Neoadjuvant Therapy in Participants With High-risk Prostate Carcinoma for Whom Radical Prostatectomy is Indicated
This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma.
Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- The Prostate Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network, Princess Margaret Cancer Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Willing and able to provide informed consent;
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a minimum of 3 cores positive for tumour;
- Tumour biopsy tissue accessible for downstream evaluation;
- Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation;
- High Risk D'Amico score defined as either PSA > 20, Gleason score ≥ 8 as determined by the local pathologist; or T2c-3 based on DRE, pathologic review +/- imaging;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- No evidence of metastatic disease or nodal disease as determined by radionuclide bone scans and computed tomography (CT)/magnetic resonance imaging (MRI); non-pathological lymph nodes must be less than 15 mm in the short (transverse) axis;
- Able to swallow the study drug(s) as prescribed and comply with study requirements;
- Required initial laboratory values:
- Absolute neutrophil count (ANC) ≥ 1500/μL;
- Platelet count ≥ 100,000/μL;
- Hemoglobin ≥ 90 g/L;
- Creatinine ≤ 175 μmol/L;
- Bilirubin ≤ upper limit of institutional normal (ULN);
- AST/ALT ≤ 1.5 × ULN.
Exclusion Criteria:
- Received an investigational agent within 4 weeks prior to screening;
- Stage T4 prostate cancer by clinical examination or radiologic evaluation;
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;
- Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer;
- Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization;
- History of another malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and non-muscle invasive bladder cancer;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiovascular disease, unstable angina pectoris, cardiac arrhythmia that is symptomatic or requires active therapy; deep venous thrombosis within 3 months prior to randomization;
- Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988);
- Liver injury or disease (e.g., viral hepatitis, liver failure Child-Pugh Class C).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abiraterone acetate + prednisone + leuprolide + cabazitaxel
Participants randomized to this arm will receive abiraterone acetate (1000 mg/day), prednisone (5 mg twice daily), leuprolide (22.5 mg every 3 months), and cabazitaxel (20 mg/m2, with 6 mg pegfilgrastim administered 24 h following cabazitaxel) prior to radical prostatectomy.
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Abiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks.
Leuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks.
Cabazitaxel will be administered in 6 cycles, with 20 mg/m2 per cycle and 3 weeks between cycles.
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Active Comparator: Abiraterone acetate + prednisone + leuprolide
Participants randomized to this arm will receive abiraterone acetate (1000 mg/day) , prednisone (5 mg twice daily), and leuprolide (22.5 mg every 3 months) prior to radical prostatectomy.
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Abiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks.
Leuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathological complete response
Time Frame: 24 weeks from start of treatment.
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24 weeks from start of treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-operative PSA levels
Time Frame: 24 weeks of treatment
|
The effect of neoadjuvant leuprolide, and abiraterone acetate and prednisone with and without cabazitaxel on pre-operative PSA will be evaluated.
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24 weeks of treatment
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Mean nadir PSA levels
Time Frame: 24 weeks of treatment
|
The effect of neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel on mean nadir PSA levels will be evaluated.
|
24 weeks of treatment
|
Percentage of participants achieving a PSA < 0.2 ng/mL
Time Frame: 24 weeks of treatment
|
The percentage of participants achieving a PSA < 0.2 ng/mL following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
|
24 weeks of treatment
|
Percentage of participants achieving a 50 and 90% decrease in PSA levels
Time Frame: up to 24 weeks of treatment
|
The percentage of participants achieving a 50 and 90% decrease in PSA levels following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
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Rate of positive surgical margins
Time Frame: up to 24 weeks of treatment
|
The rate of positive surgical margins following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
|
Rate of near-complete response (<5 mm tumour)
Time Frame: up to 24 weeks of treatment
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The rate of near-complete response (<5 mm tumour) following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
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Rate of extracapsular extension
Time Frame: up to 24 weeks of treatment
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The rate of extracapsular extension following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
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Rate of positive seminal vesicle involvement
Time Frame: up to 24 weeks of treatment
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The rate of positive seminal vesicle involvement following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
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Rate of nodal involvement
Time Frame: up to 24 weeks of treatment
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The rate of nodal involvement following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
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Tumour proliferation (Ki-67 index)
Time Frame: up to 24 weeks of treatment
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Tumour proliferation, indexed using Ki-67 immunohistochemistry, following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
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up to 24 weeks of treatment
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Androgen receptor expression
Time Frame: up to 24 weeks of treatment
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Androgen receptor expression will be evaluated using immunohistochemistry following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel.
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up to 24 weeks of treatment
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Incidence of adverse events
Time Frame: up to 24 weeks of treatment
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Incidence of adverse events will be evaluated for the duration of the study.
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up to 24 weeks of treatment
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Severity of adverse events
Time Frame: Aup to 24 weeks of treatment
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Severity of adverse events will be evaluated for the duration of the study.
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Aup to 24 weeks of treatment
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Androgen levels (if optional biopsy tissue is available)
Time Frame: up to 24 weeks of treatment
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If the participants agrees to optional pre-treatment biopsy, androgen levels will be compared between the pre-treatment tissue samples and prostatectomy tissue.
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up to 24 weeks of treatment
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Genomic alterations between pre- and post-treatment tissue
Time Frame: up to 24 weeks of treatment
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If the participants agrees to optional pre-treatment biopsy, genomic alterations between the pre-treatment tissue samples and prostatectomy tissue will be evaluated.
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up to 24 weeks of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neil E Fleshner, MD, MPH, FRCSC, University Health Network, Toronto
- Principal Investigator: Anthony Joshua, BSc (Med), MBBS, PhD, FRACP, University Health Network, Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
May 27, 2021
Study Completion (Actual)
July 20, 2021
Study Registration Dates
First Submitted
September 3, 2015
First Submitted That Met QC Criteria
September 4, 2015
First Posted (Estimated)
September 7, 2015
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Leuprolide
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- 15-051 (Wichita Medical Research and Education Foundation IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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