NCT06592924|RecruitingPhase 3DMCFDA Drug

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

TRIPLE-SWITCH

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

Canadian Cancer Trials Group ClinicalTrials.gov

Compare

2 other identifiers

CCTG-PR26NCI-2024-07535

Study Type

interventional

Target

830

Locations

2 countries

Sites

368

Timeline

RegisteredSep 2024

StartedMay 2025

CompletionApr 2031

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

830

participants targeted

Target at P75+ for phase_3

Timeline

59mo left

Started May 2025

Longer than P75 for phase_3

Geographic Reach

2 countries

368 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

Study Progress18%

May 2025Apr 2031

First Submitted

Initial submission to the registry

September 9, 2024

Completed

10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed

8 months until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2031

Expected

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2031

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

5.8 years

First QC Date

September 9, 2024

Last Update Submit

June 9, 2026

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

PR26Castration sensitive

Outcome Measures

Primary Outcomes (1)

Overall Survival
39 months

Secondary Outcomes (4)

PSA Progression compared in both arms
39 months
PSA Response comparison between arms
39 months
PSA Kinetics compared between both arms
39 months
Clinical progression-free survival between both arms
39 months

Study Arms (2)

Standard ADT + ARPI

ACTIVE COMPARATOR

Drug: AbirateroneDrug: EnzalutamideDrug: ApalutamideDrug: Darolutamide (BAY 1841788)Drug: ADT

Docetaxel + Standard ADT + ARPI

EXPERIMENTAL

Drug: AbirateroneDrug: EnzalutamideDrug: ApalutamideDrug: Darolutamide (BAY 1841788)Drug: DocetaxelDrug: ADT

Interventions

AbirateroneDRUG

Assigned prior to enrollment

Docetaxel + Standard ADT + ARPIStandard ADT + ARPI

EnzalutamideDRUG

Assigned prior to enrollment

Docetaxel + Standard ADT + ARPIStandard ADT + ARPI

ApalutamideDRUG

Assigned prior to enrollment

Docetaxel + Standard ADT + ARPIStandard ADT + ARPI

ADTDRUG

Physician's choice. Assigned prior to enrollment

Docetaxel + Standard ADT + ARPIStandard ADT + ARPI

Darolutamide (BAY 1841788)DRUG

Assigned prior to enrollment

Docetaxel + Standard ADT + ARPIStandard ADT + ARPI

DocetaxelDRUG

Assigned at enrollment

Docetaxel + Standard ADT + ARPI

Eligibility Criteria

Age18 Years+

Sexmale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
Candidate for docetaxel chemotherapy
ECOG Performance Status (PS) 0 to 2.
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.
+4 more criteria

You may not qualify if:

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:
Prior treatment with taxane chemotherapy
Grade 2 or worse peripheral neuropathy
Severe hypersensitivity to drugs formulated with polysorbate 80
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.
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.
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologycollaborator
Canadian Cancer Trials Grouplead
Alliance for Clinical Trials in Oncologycollaborator
ECOG-ACRIN Cancer Research Groupcollaborator
SWOG Cancer Research Networkcollaborator

Study Sites (368)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Alaska Breast Care and Surgery LLC