Prostate Cancer > Goserelin
~37 spots leftby Apr 2026

S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

Recruiting in Palo Alto (17 mi)
+233 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Southwest Oncology Group
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.

Research Team

LM

L. Michael Glode, MD

Principal Investigator

University of Colorado, Denver

NA

Nancy A. Dawson, MD

Principal Investigator

University of Maryland Greenebaum Cancer Center

Eligibility Criteria

Inclusion Criteria

pT3b (seminal vesicle), pT4, or N1
Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical prostatectomy and lymph node dissection
Must have undergone prostatectomy within the past 120 days
See 7 more

Treatment Details

Interventions

  • Goserelin (Hormone Therapy)
  • Mitoxantrone Hydrochloride (Alkylating agents)
  • Prednisone (Corticosteroid)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: bicalutamide, goserelin, mitoxantrone, prednisoneExperimental Treatment4 Interventions
androgen deprivation plus mitoxantrone, prednisone
Group II: bicalutamide, goserelinActive Control2 Interventions
androgen deprivation

Goserelin is already approved in Canada, Japan for the following indications:

🇨🇦
Approved in Canada as Zoladex for:
  • Prostate cancer
  • Breast cancer
  • Endometriosis
  • Uterine fibroids
🇯🇵
Approved in Japan as Zoladex for:
  • Prostate cancer
  • Breast cancer
  • Endometriosis
  • Uterine fibroids

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
CCOP - Western Regional, ArizonaPhoenix, AZ
Sutter Health - Western Division Cancer Research GroupGreenbrae, CA
Rush-Copley Cancer Care CenterAurora, IL
La Grange Memorial HospitalLa Grange, IL
More Trial Locations
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Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials
389
Patients Recruited
260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials
403
Patients Recruited
267,000+

National Cancer Institute (NCI)

Collaborator

Trials
14080
Patients Recruited
41,180,000+

Cancer and Leukemia Group B

Collaborator

Trials
81
Patients Recruited
118,000+
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