Docetaxel + Hormone Therapy for Prostate Cancer

(TRIPLE-SWITCH Trial)

Recruiting at 266 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding the drug docetaxel, a type of chemotherapy, to standard hormone therapies can more effectively prevent prostate cancer from growing or spreading. The standard approach involves hormone treatments known as ADT and ARPI. The trial seeks participants with confirmed prostate cancer that has metastasized and who have been on hormone therapy for a certain period. Participants should also be eligible for docetaxel chemotherapy. The trial aims to determine if the new treatment combination is more effective than the usual approach. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI) as part of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that docetaxel is generally safe for treating prostate cancer, especially when combined with standard treatments. In one study, patients who received docetaxel lived longer than those who did not. However, like most treatments, docetaxel can cause side effects. Some patients experienced serious side effects, but these were rare.

Another study found that only a small number of patients (1.9%) died within 30 days of starting treatment with docetaxel. Most patients tolerated the treatment well. Adding docetaxel may help control cancer growth and is relatively safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about the treatment combining Docetaxel with hormone therapy for prostate cancer because it adds a powerful chemotherapy agent to the standard hormone treatment, potentially boosting effectiveness. Most prostate cancer treatments focus on hormone therapy, like androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), to slow cancer growth by cutting off its fuel source. Docetaxel works differently by interfering with cancer cell division, which can help reduce tumor size and slow disease progression. This combination has the potential to enhance the overall treatment impact, offering hope for improved outcomes in patients with advanced prostate cancer.

What evidence suggests that adding Docetaxel to hormone therapy might be an effective treatment for prostate cancer?

Research shows that adding docetaxel to hormone therapy can effectively treat prostate cancer. In this trial, participants will be assigned to different treatment arms. One arm will receive Docetaxel combined with Standard ADT and ARPI, while another will receive Standard ADT and ARPI without Docetaxel. Studies have found that docetaxel helps people live longer and reduces the chance of cancer spreading. In one study, docetaxel led to a significant 70% reduction in deaths specifically from prostate cancer. Another study demonstrated that it extends the lives of men with both types of metastatic prostate cancer: those resistant to hormone therapy and those who are not. This suggests that combining docetaxel with standard hormone therapy could improve treatment outcomes for patients. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40276087/

Real‑world data on the outcomes of upfront docetaxel in ... The present study demonstrated that upfront docetaxel chemotherapy may be an effective and tolerable treatment for hormone-sensitive metastatic ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225005103

Article Real-world effectiveness of novel hormonal agents ... Our results indicate that patients treated with NHAs experience comparable OS and PSA-PFS to those treated with docetaxel, yet they require less ...

3. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.15046

Real‑world data on the outcomes of upfront docetaxel ... The present study demonstrated that upfront docetaxel chemotherapy may be an effective and tolerable treatment for hormone‐sensitive metastatic prostate cancer.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811171

Mortality Risk for Docetaxel-Treated, High-Grade Prostate ... Docetaxel has been shown to prolong overall survival (OS) in men with castrate-resistant and castrate-sensitive metastatic prostate cancer.

5. brighamhealthonamission.org brighamhealthonamission.org/2023/11/06/docetaxel-found-to-be-significantly-associated-with-reduced-prostate-cancer-mortality-in-patients-with-otherwise-poor-prognosis/

Docetaxel Found to Be Significantly Associated With ... SOC plus docetaxel was associated with a significant 70% reduction in prostate cancer-specific mortality (PCSM) and a nearly halved all-cause mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10620614/

Mortality Risk for Docetaxel-Treated, High-Grade Prostate ... Among the 139 patients with performance status of 0, 27 died (19.4%; 17 in the SOC group and 10 in the SOC plus docetaxel group); of these ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118315024

The efficacy and safety comparison of docetaxel ... It was found that early introduction of docetaxel in mHSPC patients had a significant OS benefit. Similar results were also found in the STAMPEDE trail [45] for ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01283

The Randomized, Double-Blind, Phase III KEYNOTE-921 ... The addition of pembrolizumab to docetaxel did not significantly improve efficacy outcomes for participants with previously treated mCRPC.

9. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/98768-real-world-uptake-safety-profile-and-outcomes-of-docetaxel-in-newly-diagnosed-metastatic-prostate-cancer.html

Real World Uptake, Safety Profile and Outcomes of ... Two patients (1.9%) died within 30 days of chemotherapy. Patients who received ADT alone had an increased risk of progression (HR 2.03, 95% CI ( ...

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa040720

Docetaxel plus Prednisone or Mitoxantrone ... When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level ...