Androgen Ablation Therapy + Chemotherapy for Prostate Cancer
(CHAARTED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates the effectiveness of combining androgen-ablation therapy with chemotherapy for treating metastatic prostate cancer. Androgens can fuel prostate cancer growth, so androgen-ablation therapy aims to stop these hormones from being produced. The trial will compare this approach alone to its combination with docetaxel, a chemotherapy drug that kills cancer cells or stops them from dividing. Ideal participants are men with metastatic prostate cancer who have been on androgen-deprivation therapy for less than four months. 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. However, concurrent antiandrogen therapy is allowed, but not as the only hormonal therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining hormone therapy with the chemotherapy drug docetaxel has been tested for safety in treating prostate cancer. Studies indicate that this combination can extend the lives of patients with advanced prostate cancer.
Safety information from these studies suggests that the treatment is generally well-tolerated. However, like most cancer treatments, some patients experienced side effects, such as tiredness, nausea, and lower blood cell counts, which are common with chemotherapy. Despite these side effects, the treatment offers significant benefits in managing cancer.
Previous patients who received this combination therapy demonstrated that it is a practical option with manageable risks for many. It is important to discuss any concerns with a healthcare provider before considering joining a clinical trial.12345Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about combining androgen-deprivation therapy with docetaxel for prostate cancer because it offers a potentially more powerful approach than standard hormone therapy alone. Androgen-deprivation therapy typically reduces male hormones that fuel cancer growth, but adding docetaxel, a chemotherapy drug, provides a double punch by directly attacking cancer cells. This combination could lead to better outcomes by slowing disease progression more effectively than hormone therapy alone.
What evidence suggests that this trial's treatments could be effective for metastatic prostate cancer?
Research has shown that combining hormone therapy with the chemotherapy drug docetaxel can benefit people with prostate cancer that has spread. In this trial, one group of participants will receive both androgen-deprivation therapy and docetaxel, while another group will receive only androgen-deprivation therapy. Studies have found that adding docetaxel to hormone therapy can extend life compared to hormone therapy alone. Specifically, one study found that starting treatment with six cycles of docetaxel led to longer survival. Another study demonstrated that this combination not only extended life but also delayed cancer progression. This suggests that using both treatments together can be more effective than hormone therapy alone.26789
Who Is on the Research Team?
Christopher Sweeney, MBBS
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for men with metastatic prostate cancer who have not been on androgen-deprivation therapy for more than 120 days. They should be in good enough health to participate, as indicated by specific blood counts and organ function tests. Men must agree to use contraception, and they can't join if they've had certain other cancers or heart problems, severe allergies to docetaxel components, or prior hormone therapy in the metastatic setting.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive androgen-deprivation therapy with or without docetaxel chemotherapy. Docetaxel is administered intravenously every 21 days for up to 6 courses.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up includes assessments every 3 months for the first 2 years, every 6 months for the next 3 years, and annually thereafter.
What Are the Treatments Tested in This Trial?
Interventions
- Androgen-deprivation therapy
- Docetaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator