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Trial Title:
Docetaxel and Hormone Treatment Compared to Hormone Treatment Alone in People With Metastatic Castration Sensitive Prostate Cancer and Less Than Optimal PSA Response
NCT ID:
NCT06592924
Condition:
Prostate Cancer (Adenocarcinoma)
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Docetaxel
Conditions: Keywords:
PR26
Castration sensitive
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone
Description:
Assigned prior to enrollment
Arm group label:
Docetaxel + Standard ADT + ARPI
Arm group label:
Standard ADT + ARPI
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
Assigned prior to enrollment
Arm group label:
Docetaxel + Standard ADT + ARPI
Arm group label:
Standard ADT + ARPI
Intervention type:
Drug
Intervention name:
Apalutamide
Description:
Assigned prior to enrollment
Arm group label:
Docetaxel + Standard ADT + ARPI
Arm group label:
Standard ADT + ARPI
Intervention type:
Drug
Intervention name:
Darolutamide (BAY 1841788)
Description:
Assigned prior to enrollment
Arm group label:
Docetaxel + Standard ADT + ARPI
Arm group label:
Standard ADT + ARPI
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Assigned at enrollment
Arm group label:
Docetaxel + Standard ADT + ARPI
Intervention type:
Drug
Intervention name:
ADT
Description:
Physician's choice. Assigned prior to enrollment
Arm group label:
Docetaxel + Standard ADT + ARPI
Arm group label:
Standard ADT + ARPI
Summary:
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).
Detailed description:
This is an international multi-centre, open-label, randomized phase III trial comparing
Docetaxel chemotherapy added to standard of care Androgen Deprivation Therapy (ADT) +
Androgen-Receptor Pathway Inhibitor (ARPI) versus standard of care Androgen Deprivation
Therapy (ADT) + Androgen-Receptor Pathway Inhibitor (ARPI) in participants with
metastatic castration sensitive prostate cancer (mCSPC) who have a suboptimal PSA
response after 6-12 months of androgen-targeting therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically/cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease by conventional imaging
- PSA of ≥5.0 ng/ml (5.0 ug/L) prior to commencement of ADT
- Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months at time
of enrollment.
- Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or
darolutamide) for at least 4 months at time of enrollment
- Potential trial participants should have recovered from clinically significant
adverse events of their most recent therapy/intervention prior to enrollment.
- Serum testosterone <1.7 nmol/L or 50 ng/dL.
- PSA ≥ 0.2 ng/ml (0.2 ug/L) within 14 days of enrollment. If there is any rise in PSA
since starting ADT and achieving castrate-level testosterone, PSA must be repeated
and must not fulfill ineligibility criteria 4.2.1.
- Candidate for docetaxel chemotherapy
- ECOG Performance Status (PS) 0 to 2.
- Adequate organ and marrow function measured within 14 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 5 working days
of participant enrollment.
- If the participant and the participant's partner are of childbearing potential, they
must agree to use medically accepted methods of contraception
- HIV-infected participants on effective anti-retroviral therapy with undetectable
viral load within 6 months are eligible for this trial.
- Participant access to all protocol therapies must be confirmed prior to enrollment
Exclusion Criteria:
- Two consecutive rises in PSA since achieving castration on ADT at least 2 weeks
apart with at least one PSA ≥5% above the PSA nadir and with at least one PSA having
an absolute increase of ≥0.5 ng/ml above the PSA nadir.
- Evidence of radiographic progression or clinical progression since start of ADT.
- Docetaxel criteria:
- Prior treatment with taxane chemotherapy
- Grade 2 or worse peripheral neuropathy
- Severe hypersensitivity to drugs formulated with polysorbate 80
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class II or better.
- 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.
- 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.
- High-grade neuroendocrine prostate cancer or small cell features.
Gender:
Male
Gender based:
Yes
Gender description:
Assigned male at birth
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 15, 2025
Completion date:
April 15, 2031
Lead sponsor:
Agency:
Canadian Cancer Trials Group
Agency class:
Other
Collaborator:
Agency:
ECOG-ACRIN Cancer Research Group
Agency class:
Other
Collaborator:
Agency:
NRG Oncology
Agency class:
Other
Collaborator:
Agency:
Alliance for Clinical Trials in Oncology
Agency class:
Other
Collaborator:
Agency:
SWOG Cancer Research Network
Agency class:
Other
Source:
Canadian Cancer Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06592924
