ADT with or without Docetaxel for Prostate Cancer

Overseen By Study Coordinator

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Northwestern University

Must be taking: ADT

Must not be taking: Second generation ARPIs

Disqualifiers: Stroke, Myocardial infarction, Uncontrolled hypertension, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatment combinations for men with low-volume metastatic hormone-sensitive prostate cancer. One group receives Androgen Deprivation Therapy (ADT) plus abiraterone, while the other receives ADT, abiraterone, and docetaxel (a chemotherapy drug). The researchers aim to determine if adding docetaxel leads to better outcomes. Men whose prostate cancer has spread to a few bones or lymph nodes outside the pelvis, without affecting other organs, may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use certain medications like strong CYP3A4 inhibitors or participate in another clinical study with investigational drugs. It's best to discuss your current medications with the trial team.

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

Research shows that combining abiraterone with androgen deprivation therapy (ADT) is generally safe for patients with prostate cancer. Studies found that using abiraterone with ADT reduces the risk of dying from prostate cancer compared to using ADT alone. Common side effects include high blood pressure and low potassium levels.

Adding docetaxel, a chemotherapy drug, to this treatment has also been studied. When used with ADT and abiraterone, it improved survival rates compared to using ADT alone. This combination, however, can cause more intense side effects, such as fatigue, low blood cell counts, and a higher risk of infection.

In summary, both treatments in the trial have shown safety in previous studies. The abiraterone and ADT combination is generally well-tolerated, while adding docetaxel can lead to more side effects but has shown a survival benefit. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine multiple therapies to tackle prostate cancer from different angles. Unlike the standard of care, which typically involves androgen deprivation therapy (ADT) alone or with docetaxel, these treatments add abiraterone to the mix. Abiraterone works by blocking the production of androgens, which fuel prostate cancer growth, providing a more comprehensive attack on the cancer cells. This combination approach aims to enhance treatment effectiveness and delay cancer progression, offering new hope for patients with prostate cancer.

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

Research shows that combining androgen deprivation therapy (ADT) with abiraterone, which participants in the Doublet Arm of this trial may receive, significantly lowers the risk of death compared to ADT alone. Specifically, studies indicate a 27% reduction in the risk of death with this combination. Another study found that this treatment combination can reduce the impact of prostate cancer in the body. Participants in the Triplet Arm of this trial will receive ADT and abiraterone with the addition of docetaxel, which may improve survival rates further, especially for patients with a large amount of cancer. However, for those with a smaller amount of cancer, the benefits might not be as significant. Overall, combining these treatments offers a promising approach for people with metastatic hormone-sensitive prostate cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Sarah Fenton

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Men with low volume metastatic hormone-sensitive prostate cancer who have started androgen deprivation therapy within the last 12 weeks. They must be in good physical condition (ECOG ≤1), have proper organ and bone marrow function, understand the study, and consent to participate. No prior chemotherapy for prostate cancer is allowed, except as specified.

Inclusion Criteria

My prostate cancer has spread, confirmed by scans.

I started hormone therapy for my cancer less than 12 weeks ago.

My cancer has spread to a few bones or lymph nodes but not to my organs.

Exclusion Criteria

You are not currently participating in any other experimental treatments.

Known hypersensitivity to any of the study drugs, study drug classes or excipients in the formation of any of the study drugs.

My hepatitis B is under control with treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm). Abiraterone is administered in 12-week cycles, and docetaxel is given on day 1 of each 21-day cycle.

12 weeks

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of progression-free survival and overall survival.

Up to 1 year

Quality of Life Assessment

Quality of Life is assessed using the FACT-P QoL assessment tool.

Throughout treatment and up to 30 days after the last dose

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone
• ADT
• Docetaxel

Trial Overview This trial compares two treatments: ADT + abiraterone versus ADT + abiraterone + docetaxel for first-line therapy in men with low volume mHSPC. It's a phase II study where patients are randomly assigned to one of these treatment arms to see which provides better outcomes.

How Is the Trial Designed?

Group I: Triplet Arm Experimental Treatment 3 Interventions

Abiraterone+Docetaxel+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion. ADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT.

Group II: Doublet Arm Active Control 2 Interventions

Abiraterone+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Treatment of abiraterone should start ≤14 days after patient randomization. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.

Abiraterone is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Zytiga for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC)

Approved in European Union as Zytiga for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC)

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC)

Approved in Japan as Zytiga for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Metastatic high-risk castration-sensitive prostate cancer (mCSPC)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 196 men with metastasized hormone-sensitive prostate cancer, the combination of abiraterone acetate (AA) and androgen deprivation therapy (ADT) showed significantly longer progression-free survival (PFS1: 23 months vs. 13 months) and overall survival (OS: 80 months vs. 61 months) compared to docetaxel (D) and ADT.

Both treatment regimens had similar overall toxicity rates, suggesting that while AA+ADT may offer better progression-free outcomes, it does not increase the risk of adverse effects compared to D+ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-world comparison of docetaxel versus abiraterone acetate for metastatic hormone-sensitive prostate cancer. Tsaur, I., Heidegger, I., Bektic, J., et al.[2022]

Abiraterone is considered a cost-effective treatment for metastatic castration-resistant prostate cancer (mCRPC) at $94,000 per quality-adjusted life year (QALY) compared to placebo, based on a decision-tree model analyzing various treatment options over 18 months.

Cabazitaxel, while effective, is not cost-effective compared to abiraterone, with an incremental cost-effectiveness ratio of $956,000 per QALY, indicating that it may not be a viable option for patients after docetaxel failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic options in docetaxel-refractory metastatic castration-resistant prostate cancer: a cost-effectiveness analysis. Zhong, L., Pon, V., Srinivas, S., et al.[2023]

Adding docetaxel or abiraterone to androgen-deprivation therapy (ADT) significantly improves overall survival in men with newly diagnosed metastatic prostate cancer, based on evidence from multiple studies involving thousands of participants.

The strongest survival benefits from docetaxel are observed in patients with high-volume metastatic disease, while abiraterone also shows similar benefits in high-risk patients, indicating both treatments are effective options alongside ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Anticancer Therapy in Metastatic Non-Castrate Prostate Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Morris, MJ., Rumble, RB., Basch, E., et al.[2019]

Cabazitaxel, abiraterone, and enzalutamide have been shown to significantly prolong overall survival in men with metastatic castration-resistant prostate cancer who have previously undergone chemotherapy, based on randomized phase 3 clinical trials.

The introduction of these new treatments has led to their approval and reimbursement in Belgium, marking an important advancement in options for patients with docetaxel-resistant prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New treatments for castration-resistant prostate cancer]. Sautois, B., Gennigens, C.[2021]

In a study of 773 men with metastatic hormone-sensitive prostate cancer, the combination of docetaxel and androgen deprivation therapy (ADT) showed similar progression-free survival (PFS) and overall survival (OS) benefits across different age groups, indicating its efficacy regardless of age.

Older men (over 70 years) experienced a modest increase in the number of adverse events compared to younger men, suggesting that while the treatment is effective, careful consideration of potential side effects is crucial for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Adverse Events of Docetaxel for Metastatic, Hormone-sensitive Prostate Cancer Among Elderly Men: A Post Hoc Analysis of the CHAARTED Trial. Li, EV., Siddiqui, MR., Weiner, AB., et al.[2022]

A systematic review of 6067 patients from five trials found that both abiraterone acetate plus ADT (Abi-ADT) and docetaxel plus ADT (Doce-ADT) significantly improved overall survival compared to ADT alone, with hazard ratios of 0.63 and 0.75 respectively.

There was no statistically significant difference in overall survival between Abi-ADT and Doce-ADT, but Bayesian analysis suggested an 89% probability that Abi-ADT might be the preferred treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Abiraterone Acetate and Docetaxel with Androgen Deprivation Therapy in High-risk and Metastatic Hormone-naïve Prostate Cancer: A Systematic Review and Network Meta-analysis. Wallis, CJD., Klaassen, Z., Bhindi, B., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8092456/

Abiraterone acetate in combination with androgen deprivation ... Abiraterone acetate in addition to ADT probably reduces the probability of death due to prostate cancer compared to ADT alone (HR 0.58, 95% CI 0.50 to 0.68; 2 ...

2. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00690

Real-World Evidence of Combination Therapy Use in ... ADT combination with abiraterone + DOC is supported by clinical trial data (PEACE-1) but is not FDA-approved. ADT, androgen-deprivation therapy; ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1704174

Abiraterone plus Prednisone in Metastatic, Castration- ... A significant 27% reduction in the relative risk of death (and a reduction of 37% in patients with high-volume disease) with androgen- ...

4. nature.com nature.com/articles/s41391-024-00816-0

Real-world overall survival with abiraterone acetate versus ... Comparison of real-life data of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer. Sci Rep. 2021;11 ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2025/10100/systemic_treatment_of_metastatic.53.aspx

Systemic treatment of metastatic castration-sensitive... The ADT combination in M1 patients had better outcomes, in descending order of abiraterone acetate (HR = 0.61, 95% CI = 0.49–0.77) ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa1702900

Abiraterone for Prostate Cancer Not Previously Treated ... The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2588931124000282

A 3-year Interim Analysis of the Observational J-ROCK Study In this study, we compared clinical and safety outcomes with different treatment regimens, using a large series of patients with high-risk metastatic hormone- ...

8. jnj.com jnj.com/media-center/press-releases/new-data-presented-at-esmo-2017-shows-that-abiraterone-acetate-plus-prednisone-provides-benefits-in-patient-reported-outcomes-in-both-metastatic-hormone-sensitive-and-castration-resistant-prostate-cancer

New Data Presented at ESMO 2017 Shows That ... The most common and anticipated adverse events were elevated incidences of mineralocorticoid-related hypertension and hypokalaemia in the ADT in ...