Chemotherapy + Hormone Therapy With Surgery for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+225 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.

Research Team

James Eastham, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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 18 years old or older.

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.

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.

Treatment Details

Interventions

• Docetaxel (Taxane Chemotherapy)
• Goserelin (LHRH Agonist)
• Leuprolide (LHRH Agonist)
• Surgery (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.

Participant Groups

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+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

Dr. Mitchell D. Schnall

Eastern Cooperative Oncology Group

Chief Medical Officer

MD, PhD from University of Pennsylvania

Dr. Peter J. O'Dwyer

Eastern Cooperative Oncology Group

Chief Executive Officer

MD from University of Pennsylvania

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+

Dr. Lesley Seymour

NCIC Clinical Trials Group

Chief Medical Officer since 2014

MD from University of Toronto

Dr. Janet Dancey

NCIC Clinical Trials Group

Chief Executive Officer since 2014

MD from Queen's University