PHASE3RECRUITING

Comparing Abiraterone with Docetaxel for prostate cancer (adenocarcinoma)

Official title: Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Condition: Prostate Cancer (Adenocarcinoma)Sponsor: Canadian Cancer Trials GroupTarget enrollment: 830

Interventions

DRUG

Abiraterone

Assigned prior to enrollment

DRUG

Enzalutamide

Assigned prior to enrollment

DRUG

Apalutamide

Assigned prior to enrollment

DRUG

Darolutamide (BAY 1841788)

Assigned prior to enrollment

DRUG

Docetaxel

Assigned at enrollment

DRUG

ADT

Physician's choice. Assigned prior to enrollment

Canadian Sites (19)

Cross Cancer Institute

Edmonton, Alberta, Canada

RECRUITING

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Atlantic Health Sciences Corporation-Saint John Regional Hospital

Saint John, New Brunswick, Canada

RECRUITING

Health Sciences North

Greater Sudbury, Ontario, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

RECRUITING

Waterloo Regional Health Network

Kitchener, Ontario, Canada

RECRUITING

London Regional Cancer Program

London, Ontario, Canada

RECRUITING

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, Canada

RECRUITING

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

RECRUITING

Niagara Health System-Saint Catharines General

Saint Catharines, Ontario, Canada

RECRUITING

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

RECRUITING

CSSS Champlain-Charles Le Moyne

Greenfield Park, Quebec, Canada

RECRUITING

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

CHA Hopital L'Enfant-Jesus

Québec, Quebec, Canada

RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

RECRUITING

See who this study is looking for35 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+ECOG Performance Status (PS) 0 to 2.
+HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
+Histologically/cytologically confirmed adenocarcinoma of the prostate or participants with a PSA \>100 ng/ml (100 ug/L) and radiographic evidence of metastatic disease at diagnosis.
+Metastatic disease by conventional imaging (bone scan or CT and/or MRI or PSMA-PET scan at the time of ADT initiation.
+PSA of ≥ 2.0 ng/ml (2.0 ug/L) prior to commencement of ADT (this refers to patients who have histologically/cytologically confirmed adenocarcinoma of the prostate)
+Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).
+Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry.
+Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+/- 3 weeks) at time of enrollment.
+Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+/- 2 weeks) at time of enrollment
+Patients may have had radiotherapy to prostatic bed and/or metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.
+Serum testosterone \<1.7 nmol/L or 50 ng/dL.
+PSA ≥ 0.2 ng/ml (0.2 ug/L) within 28 days of enrollment.
+Adequate organ and marrow function measured within 28 days prior to enrollment.
+Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
+Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
+In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment.
+Participant access to all protocol therapies must be confirmed prior to enrollment
+If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception
+Candidate for docetaxel chemotherapy

Exclusion

−Severe hypersensitivity to drugs formulated with polysorbate 80
−For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
−Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
−Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng/ml (ug/L) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks.
−Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect.
−Docetaxel criteria:
−Grade 2 or worse peripheral neuropathy
−Clinically significant cardiac disease including:
−History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.
−History of documented congestive heart failure (New York Heart Association functions classification III-IV).
−Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
−Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
−Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.
−Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
−High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \>100 ng/ml (\>100 ug/L) at diagnosis and radiographic evidence of metastatic disease)
−Prior treatment with taxane chemotherapy

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 3 — a large study comparing this against the current standard, usually across many hospitals.

What is being given or done in this study: Abiraterone, Enzalutamide, Apalutamide, Darolutamide (BAY 1841788), and 2 more.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases
armsInterventionsModule.interventions[].name

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

There are 2 groups in this study.

From the trial registry

Built from this field:

armsInterventionsModule.armGroups[].type

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists male participants only.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 830 people.

The study is currently expected to finish around April 2031.

The main measurement is taken over: 39 months.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Overall Survival — measured over 39 months.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06592924 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?