Docetaxel + Hormone Therapy for Prostate Cancer

(TRIPLE-SWITCH Trial)

Overseen By Mariam Jafri

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Must be taking: Androgen deprivation, ARPI

Must not be taking: Other anti-cancer therapy

Disqualifiers: Cardiac disease, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

830 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

Michael Ong

Principal Investigator

Ottawa Hospital Research Institute, Ottawa ON Canada

Alexandra Sokolova

Principal Investigator

Oregon Health and Science University, Portland, OR, USA

Eligibility Criteria

This trial is for men with metastatic castration-sensitive prostate cancer who've been on hormone treatment and an ARPI drug like abiraterone or enzalutamide for 4-12 months, but still have a PSA level of at least 0.2 ng/ml. They should be fit enough for chemotherapy, not currently experiencing significant side effects from previous treatments, and their cancer must be confirmed by lab tests.

Inclusion Criteria

My testosterone levels are below 50 ng/dL.

I can care for myself and am up and about more than 50% of my waking hours.

I have recovered from major side effects of my last treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Docetaxel chemotherapy in addition to standard Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI)

6-12 months

Follow-up

Participants are monitored for PSA response and kinetics to assess the effectiveness of the treatment

39 months

Treatment Details

Interventions

• Docetaxel

Trial Overview The study is testing if adding Docetaxel to the usual treatment (ADT plus ARPI) can better prevent prostate cancer from growing or spreading. The 'usual approach' being compared involves just ADT and an ARPI without Docetaxel.

Participant Groups

Group I: Docetaxel + Standard ADT + ARPI Experimental Treatment 6 Interventions

Group II: Standard ADT + ARPI Active Control 5 Interventions

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

ECOG-ACRIN Cancer Research Group

Collaborator

Trials

122

Recruited

160,000+

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Recruited

224,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+