Docetaxel + Hormonal Therapy for Prostate Cancer

Recruiting at 26 trial locations

Overseen By Shiva Baghaie, MPH

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: Hormonal therapy, Apalutamide

Must not be taking: Strong CYP3A4 inhibitors, inducers

Disqualifiers: Uncontrolled hypertension, Seizure conditions, 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: 6

Duration: Up to 18 weeks

1260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding docetaxel, a medication that stops tumor growth, to the usual hormonal therapy and apalutamide treatment is more effective for treating prostate cancer that has spread to other parts of the body. Hormonal therapy reduces male hormones that help cancer grow, while apalutamide blocks these hormones from affecting cancer cells. Men with prostate cancer that has metastasized and have confirmed this through specific imaging tests may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. If you are on strong CYP3A4 inhibitors or inducers, you must discontinue them before starting the study. Also, medications that lower the seizure threshold need to be stopped or replaced before entering the trial.

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

Previous studies have shown that apalutamide is safe and effective for treating prostate cancer. Research in real-world settings and clinical trials supports this, with no new safety concerns identified.

Adding docetaxel complicates the treatment. Studies have shown that combining apalutamide, docetaxel, and hormone therapy (such as ADT) can lead to more side effects, including tiredness, high blood pressure, and liver problems. However, these studies are crucial for understanding the effectiveness of this combination in treating cancer.

Overall, apalutamide alone is usually well-tolerated. While adding docetaxel might increase side effects, researchers are studying this combination to determine if it improves cancer treatment. ^{1 2 3 4 5}

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

Researchers are excited about these treatments for prostate cancer because they explore the synergy between established hormonal therapy and newer agents like apalutamide. Unlike traditional treatments that mainly focus on androgen deprivation therapy (ADT) alone, this study introduces apalutamide, which blocks androgen receptors more comprehensively, potentially enhancing the efficacy of ADT. Additionally, in one arm, the combination of apalutamide with docetaxel, a chemotherapy drug, might offer a more powerful approach to tackling aggressive prostate cancer by combining hormonal and chemotherapeutic strategies. This integrated approach aims to improve outcomes by targeting cancer from multiple angles, which could lead to better disease control and possibly longer survival rates.

What evidence suggests that this trial's treatments could be effective for metastatic prostate cancer?

Studies have shown that combining apalutamide with hormone therapy significantly lowers the risk of death in prostate cancer patients compared to some other treatments. Apalutamide also slows the growth or spread of prostate cancer for longer periods. In this trial, one group of participants will receive apalutamide with hormone therapy, while another group will receive apalutamide, hormone therapy, and docetaxel. Adding docetaxel to this combination can further improve survival rates. Research indicates that patients using docetaxel with hormone therapy live longer than those using only hormone therapy. Overall, the combination of apalutamide, hormone therapy, and docetaxel offers a promising approach for treating prostate cancer that has spread. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Men aged 18+ with metastatic prostate cancer that has spread beyond the original site. They must have had prior hormone therapy, show specific blood and organ function levels, and can't have more than four bone metastases or any visceral metastasis. Those with other cancers, treated brain metastases, HIV/HBV/HCV under control are eligible. No history of seizures or uncontrolled hypertension; no hypersensitivity to trial drugs.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

ANC ≥ 1,500/mm^3

Serum potassium ≥ 3.5 mmol/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ADT and apalutamide, with or without docetaxel, in cycles repeating every 12 weeks. Docetaxel is administered every 21 days for up to 6 doses.

Up to 18 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months.

Up to 10 years

Follow-up visits every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Apalutamide
• Docetaxel

Trial Overview The ASPIRE Trial is comparing usual treatment (hormonal therapy and apalutamide) plus docetaxel chemotherapy against the usual treatment alone for men with spreading prostate cancer. Docetaxel aims to stop tumor growth by killing cells; apalutamide blocks male hormones that fuel tumors.

How Is the Trial Designed?

Group I: Arm 2 (ADT, apalutamide, docetaxel) Experimental Treatment 9 Interventions

Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.

Group II: Arm 1 (ADT, apalutamide) Active Control 8 Interventions

Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. nature.com nature.com/articles/s41391-024-00929-6

Survival outcomes of apalutamide as a starting treatment Starting treatment with APA + ADT was associated with a significantly reduced risk of death compared with ENZ + ADT (aHR, 95%CI) (0.66, 0.51– ...

2. urotoday.com urotoday.com/video-lectures/mhspc/video/mediaitem/4763-real-world-data-explores-benefits-of-apalutamide-in-metastatic-hormone-sensitive-prostate-cancer-benjamin-maughan.html

Real-World Data Explores Benefits of Apalutamide in ... All doublet combinations showed superior outcomes compared to ADT monotherapy, with apalutamide demonstrating numerically superior results. Dr.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1903307

Apalutamide for Metastatic, Castration-Sensitive Prostate ... Apalutamide plus ADT also resulted in a higher percentage of patients in whom undetectable PSA levels were achieved and a longer time to PSA progression than ...

4. jheor.org jheor.org/article/121233-real-world-clinical-outcomes-and-treatment-patterns-among-black-and-non-black-patients-with-prostate-cancer-initiated-on-apalutamide-in-a-urology-sett

Real-World Clinical Outcomes and Treatment Patterns ... In the TITAN trial, evaluating the efficacy of apalutamide in patients with mCSPC, the 24-month progression to CR rate was 32.3% (Janssen ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39613567/

Results from the Multicenter Real-world ARON-3 Study Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.352

Safety and quality of life analyses of apalutamide plus ... No new safety issues were observed and the safety profile was consistent relative to those previously described with apalutamide and castration, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2588931124002530

Apalutamide in Metastatic Castration-sensitive Prostate ... Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.