Chemotherapy + Hormone Therapy With Surgery for Prostate Cancer

Not currently recruiting at 229 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: LHRH agonists

Disqualifiers: Small cell, Neuroendocrine, Transitional, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining chemotherapy (using docetaxel) and hormone therapy (using drugs like leuprolide or goserelin) before surgery is more effective than surgery alone for treating high-risk localized prostate cancer. The goal is to determine if this combination can shrink the tumor, making surgery easier and potentially more successful. This trial suits those diagnosed with high-risk prostate cancer who have not undergone previous treatments like surgery or radiation and are candidates for prostate surgery. Participants must have a specific cancer profile, including a Gleason score of 8 or higher, with no signs of cancer spread. 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, you should not have had prior treatment for prostate cancer, except for up to 4 months of certain hormone therapies. 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?

In a previous study, 103 patients received docetaxel, and 34% required hospitalization due to side effects. The study also reported 17 cases of febrile neutropenia, characterized by fever and low white blood cell counts. However, another study found that different dosing schedules of docetaxel were generally well-tolerated by men with advanced prostate cancer.

Research has shown that goserelin, a hormone therapy, is generally safe and effective. It significantly reduces testosterone levels, aiding in prostate cancer treatment. Common side effects include hot flashes and cancer-related pain.

For leuprolide, another hormone therapy, studies indicate it is generally safe. While it may cause some heart-related effects, the overall risk appears manageable.

In summary, while these treatments carry some risks, many patients tolerate them well. Consulting a doctor is crucial to understand how these findings apply to individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining chemotherapy, hormone therapy, and surgery for prostate cancer because it offers a more comprehensive approach than traditional treatments, which often focus on just one or two strategies. Typically, standard care involves either surgery or hormone therapy alone. By integrating docetaxel, a chemotherapy drug, with LHRH agonists for hormone therapy, and following up with surgery, this method aims to attack cancer on multiple fronts. This multi-pronged strategy could potentially improve outcomes by shrinking tumors before surgery, making them easier to remove, and reducing the risk of cancer returning. Additionally, the option for adjuvant radiation therapy post-surgery adds another layer of treatment to further target any remaining cancer cells.

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

In this trial, participants in Arm A will receive a combination of the drug docetaxel with hormone therapy (such as leuprolide or goserelin) before undergoing surgery. Research has shown that this combination effectively treats prostate cancer. Studies have found that adding docetaxel to standard hormone treatments can lead to better patient outcomes. Hormone therapy stops the body from making testosterone, which can help prostate cancer grow. Docetaxel prevents cancer cells from multiplying, potentially shrinking tumors. This combination has proven beneficial in other hormone-responsive prostate cancer cases. Overall, this approach appears promising for reducing prostate tumor size before surgery. Participants in Arm B will undergo surgery without preceding chemotherapy and hormone therapy. ^{6 7 8 9 10}

Who Is on the Research Team?

James Eastham, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with high-risk localized prostate cancer who are fit for surgery and expected to live more than 10 years. They must have a specific type of prostate cancer (adenocarcinoma), no prior treatments except possibly short-term hormone therapy, and no evidence of spread beyond the prostate. Men with other recent cancers or certain blood clotting events not suitable for surgery can't join.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

My cancer is in an early stage and has not spread, as confirmed by scans.

I am a good candidate for prostate surgery and expected to live more than 10 years.

Exclusion Criteria

I have a history of blood clots or stroke and cannot undergo major prostate surgery.

I currently have cancer.

I have not had any cancer except for basal or squamous cell skin cancer in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants receive six cycles of docetaxel every 3 weeks combined with 18-24 weeks of androgen deprivation therapy

18-24 weeks

6 visits (in-person) for chemotherapy cycles

Surgical Intervention

Participants undergo standard surgical intervention within 60 days of completing neoadjuvant therapy

2 months

Adjuvant Radiation (optional)

Participants may receive adjuvant external beam radiation initiated within 6 months of surgery

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 years

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Goserelin
• Leuprolide
• Surgery

Trial Overview The study is testing if giving chemotherapy drug docetaxel along with hormone therapies leuprolide or goserelin before surgery offers better outcomes compared to just having the surgery alone. The goal is to see if this combination treatment can shrink tumors more effectively, making them easier to remove surgically.

How Is the Trial Designed?

Group I: Arm B: surgical intervention Experimental Treatment 1 Intervention

All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery.

Group II: Arm A: docetaxel + LHRH agonist + surgical intervention Experimental Treatment 3 Interventions

Patients receive six cycles of docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines. Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+

Published Research Related to This Trial

A meta-analysis of 15 randomized controlled trials involving 16,795 patients found that novel oral anti-androgens (NOAAs) are associated with a 26% increased risk of all-grade fatigue compared to standard treatments.

Interestingly, NOAAs were linked to a decreased risk of anemia, suggesting that while they may cause fatigue, they do not significantly increase the likelihood of anemia in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Fatigue and Anemia in Patients With Prostate Cancer Treated With Novel Oral Anti-androgens: A Meta-Analysis of Randomized Controlled Trials. Babkoor, AA., Aljabri, Y., Alzubaidi, A., et al.[2022]

Chemotherapy has been shown to provide significant benefits for patients with advanced prostate cancer that no longer respond to hormonal therapy, outperforming traditional palliative and hormonal treatments.

Evidence suggests that combining antitumor agents with hormonal therapy as an initial treatment for metastatic prostate cancer may be more effective than delaying chemotherapy until after hormone failure, especially in patients with poorer prognoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of experience with chemotherapy for prostate cancer. Slack, NH., Murphy, GP.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8575582/

Current treatment options for newly diagnosed metastatic ... Klotz et al. compared the efficacy and tolerability of degarelix to leuprolide in 610 men with hormone-sensitive prostate cancer. The authors found that >95% ...

2. cancer.gov cancer.gov/news-events/cancer-currents-blog/2025/metastatic-prostate-cancer-combination-treatments

Treatment for Metastatic Prostate Cancer Often Suboptimal The first hit, standard androgen deprivation therapy with drugs like goserelin and leuprolide, suppresses the production of testosterone by the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4737894/

Addition of docetaxel or bisphosphonates to standard of care ... Results from large randomised controlled trials combining docetaxel or bisphosphonates with standard of care in hormone-sensitive prostate cancer have emerged.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00430183?tab=table

Surgery With or Without Docetaxel and Leuprolide or Goserelin ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. journals.lww.com journals.lww.com/indianjcancer/fulltext/2022/59001/gonadotropin_releasing_hormone_agonists_in.12.aspx

Gonadotropin-releasing hormone agonists in prostate cancer However, goserelin has shown better efficacy in maintaining T levels ≤50 ng/dL compared with leuprolide. The incidences of T escape are lower with goserelin and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28940952/

Real-world uptake, safety profile and outcomes of ... Results: Of the 270 eligible patients, 103 received docetaxel (38.1%). 35 patients (34%) were hospitalised and there were 17 episodes of febrile neutropenia ( ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2287888224000758

Weekly versus 2-weekly versus 3-weekly docetaxel to treat ... Treatment with DCT at 2-week or even 1-week intervals appears to be well tolerated in men diagnosed with mCRPC and represents a useful option when the ...

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

The Randomized, Double-Blind, Phase III KEYNOTE-921 ... Among participants with PD-L1–positive mCRPC, median OS was 19.8 months (95% CI, 16.2 to 22.0) in the pembrolizumab plus docetaxel group versus ...

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

Docetaxel plus Prednisone or Mitoxantrone ... The median survival among patients in the mitoxantrone group in our study was 16.5 months, as compared with 10 to 12.5 months in the Canadian and Cancer and ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT00242918

Safety and Effectiveness Study of Docetaxel and ZD1839 ... The critical issue is in addressing micrometastatic disease that has already developed prior to diagnosis. This study utilizes daily doses of ZD1839 and weekly ...