Prostate CancerPhase 2ACDC-RPNCT02543255
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)
A Phase 2 study testing Abiraterone acetate with prednisone, Leuprolide and Cabazitaxel with peg-filgrastim in people with Prostate Cancer, run by University Health Network, Toronto at 5 sites in Canada.
Trial summary
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. 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?
- Abiraterone acetate with prednisone, Leuprolide and Cabazitaxel with peg-filgrastim
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2016to 20 Jul 2021
- Phase
- Phase 2
- 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
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre
London, Ontario, N6A 5W9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
The Prostate Centre
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone acetate with prednisone, Leuprolide, Cabazitaxel with peg-filgrastim
- Keywords
- High risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetate with prednisoneDrug
Abiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks.
LeuprolideDrug
Leuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks.
Cabazitaxel with peg-filgrastimDrug
Cabazitaxel will be administered in 6 cycles, with 20 mg/m2 per cycle and 3 weeks between cycles.
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate + prednisone + leuprolide + cabazitaxel | Experimental | 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. Receives: Drug: Abiraterone acetate with prednisone; Drug: Leuprolide; Drug: Cabazitaxel with peg-filgrastim |
| Abiraterone acetate + prednisone + leuprolide | Active comparator | 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. Receives: Drug: Abiraterone acetate with prednisone; Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Measured: 24 weeks from start of treatment.
Secondary outcomes (15)
Pre-operative PSA levels
The effect of neoadjuvant leuprolide, and abiraterone acetate and prednisone with and without cabazitaxel on pre-operative PSA will be evaluated.
Measured: 24 weeks of treatment
Mean nadir PSA levels
The effect of neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel on mean nadir PSA levels will be evaluated.
Measured: 24 weeks of treatment
Percentage of participants achieving a PSA < 0.2 ng/mL
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.
Measured: 24 weeks of treatment
Percentage of participants achieving a 50 and 90% decrease in PSA levels
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.
Measured: up to 24 weeks of treatment
Rate of positive surgical margins
The rate of positive surgical margins following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Measured: up to 24 weeks of treatment
Rate of near-complete response (<5 mm tumour)
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.
Measured: up to 24 weeks of treatment
Rate of extracapsular extension
The rate of extracapsular extension following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Measured: up to 24 weeks of treatment
Rate of positive seminal vesicle involvement
The rate of positive seminal vesicle involvement following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Measured: up to 24 weeks of treatment
Rate of nodal involvement
The rate of nodal involvement following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Measured: up to 24 weeks of treatment
Tumour proliferation (Ki-67 index)
Tumour proliferation, indexed using Ki-67 immunohistochemistry, following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Measured: up to 24 weeks of treatment
Androgen receptor expression
Androgen receptor expression will be evaluated using immunohistochemistry following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel.
Measured: up to 24 weeks of treatment
Incidence of adverse events
Incidence of adverse events will be evaluated for the duration of the study.
Measured: up to 24 weeks of treatment
Severity of adverse events
Severity of adverse events will be evaluated for the duration of the study.
Measured: Aup to 24 weeks of treatment
Androgen levels (if optional biopsy tissue is available)
If the participants agrees to optional pre-treatment biopsy, androgen levels will be compared between the pre-treatment tissue samples and prostatectomy tissue.
Measured: up to 24 weeks of treatment
Genomic alterations between pre- and post-treatment tissue
If the participants agrees to optional pre-treatment biopsy, genomic alterations between the pre-treatment tissue samples and prostatectomy tissue will be evaluated.
Measured: up to 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2016
- Primary completion27 May 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil E Fleshner, MD, MPH, FRCSC, Principal investigator, University Health Network, TorontoAnthony Joshua, BSc (Med), MBBS, PhD, FRACP, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543255
- Sponsor's protocol ID
- 15-051
- Acronym
- ACDC-RP
- Status last verified
- Jan 2024
- First submitted
- 3 Sep 2015
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02543255
- Acronym / sponsor ID
- ACDC-RP / 15-051
- Conditions
- Prostate Cancer
- Keywords
- High risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate + prednisone + leuprolide + cabazitaxel | Experimental | Drug: Abiraterone acetate with prednisone, Drug: Leuprolide, Drug: Cabazitaxel with peg-filgrastimParticipants 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. |
| Abiraterone acetate + prednisone + leuprolide | Active comparator | Drug: Abiraterone acetate with prednisone, Drug: LeuprolideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone acetate with prednisoneAbiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks. | Drug | Abiraterone acetate + prednisone + leuprolide, Abiraterone acetate + prednisone + leuprolide + cabazitaxel |
| LeuprolideLeuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks. | Drug | Abiraterone acetate + prednisone + leuprolide, Abiraterone acetate + prednisone + leuprolide + cabazitaxel |
| Cabazitaxel with peg-filgrastimCabazitaxel will be administered in 6 cycles, with 20 mg/m2 per cycle and 3 weeks between cycles. | Drug | Abiraterone acetate + prednisone + leuprolide + cabazitaxel |
Primary outcome
Pathological complete response
Time frame: 24 weeks from start of treatment.
15 secondary outcomes
Pre-operative PSA levels
Time frame: 24 weeks of treatment
Mean nadir PSA levels
Time frame: 24 weeks of treatment
Percentage of participants achieving a PSA < 0.2 ng/mL
Time frame: 24 weeks of treatment
Percentage of participants achieving a 50 and 90% decrease in PSA levels
Time frame: up to 24 weeks of treatment
Rate of positive surgical margins
Time frame: up to 24 weeks of treatment
Rate of near-complete response (<5 mm tumour)
Time frame: up to 24 weeks of treatment
Rate of extracapsular extension
Time frame: up to 24 weeks of treatment
Rate of positive seminal vesicle involvement
Time frame: up to 24 weeks of treatment
Rate of nodal involvement
Time frame: up to 24 weeks of treatment
Tumour proliferation (Ki-67 index)
Time frame: up to 24 weeks of treatment
Androgen receptor expression
Time frame: up to 24 weeks of treatment
Incidence of adverse events
Time frame: up to 24 weeks of treatment
Severity of adverse events
Time frame: Aup to 24 weeks of treatment
Androgen levels (if optional biopsy tissue is available)
Time frame: up to 24 weeks of treatment
Genomic alterations between pre- and post-treatment tissue
Time frame: up to 24 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil E Fleshner, MD, MPH, FRCSC principal investigator
University Health Network, Toronto
Anthony Joshua, BSc (Med), MBBS, PhD, FRACP principal investigator
University Health Network, Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone acetate with prednisone, Leuprolide and Cabazitaxel with peg-filgrastim in people with Prostate Cancer, run by University Health Network, Toronto at 5 sites in Canada.
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 15 inclusion and 9 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 31 Jan 2024. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pathological complete response (time frame: 24 weeks from start of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.