Health Trials

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

ConditionProstate Cancer (Adenocarcinoma)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCanadian Cancer Trials Group

About this trial

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?

This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.

The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Prior treatment with taxane chemotherapy

Grade 2 or worse peripheral neuropathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abiraterone

    Drug

    Assigned prior to enrollment

  • Enzalutamide

    Drug

    Assigned prior to enrollment

  • Apalutamide

    Drug

    Assigned prior to enrollment

  • Darolutamide (BAY 1841788)

    Drug

    Assigned prior to enrollment

  • Docetaxel

    Drug

    Assigned at enrollment

  • ADT

    Drug

    Physician's choice. Assigned prior to enrollment

Treatment groups

830 Participants
are divided into 2 treatment groups
Group A: Standard ADT + ARPIActive comparator 5 interventions
Group B: Docetaxel + Standard ADT + ARPIExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

Time frame
39 months

Secondary outcomes

1

PSA Progression compared in both arms

Time frame
39 months
2

PSA Response comparison between arms

PCWG3 criteria

Time frame
39 months
3

PSA Kinetics compared between both arms

* 90% PSA decline * PSA \<0.2ng/ml * PSA \<0.02ng/ml

Time frame
39 months
4

Clinical progression-free survival between both arms

Time frame
39 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

ECOG-ACRIN Cancer Research Group

Collaborator

NRG Oncology

Collaborator

Alliance for Clinical Trials in Oncology

Collaborator

SWOG Cancer Research Network

Collaborator

Source ClinicalTrials.gov
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