Phase 3 N=961 Randomized Treatment

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

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00004124 ↗

Enrolled (actual)

961

Serious AEs

1.5%

Results posted

Sep 2018

Primary outcome: Primary: Overall Survival — 87; 86 percentage of probability of survival — p=0.70

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: bicalutamide (Drug); goserelin (Drug); mitoxantrone hydrochloride (Drug); prednisone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: SWOG Cancer Research Network
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	87; 86	0.70
PRIMARY Disease Free Survival	72; 72	0.94
SECONDARY Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients	19; 41; 0; 1; 11; 11	—
SECONDARY PSA Progression Free Survival	—	—
SECONDARY PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival	—	—

Summary

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

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
Must meet at least 1 of the following pathologic criteria:
Gleason sum at least 8
pT3b (seminal vesicle), pT4, or N1
Gleason sum of 7 and positive margin
Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA level greater than 10 ng/mL and Gleason score greater than 6
Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy prior to study)
No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at clinical diagnosis
No distant metastatic disease

PATIENT CHARACTERISTICS:

Performance status:

SWOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Cardiovascular:

No uncontrolled congestive heart failure
If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram

Other:

No HIV positivity
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical prostatectomy allowed
Other concurrent adjuvant hormonal therapy allowed if initiated prior to study
Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed

Radiotherapy:

No prior radiotherapy
No concurrent whole pelvis irradiation
Concurrent radiotherapy allowed at the discretion of the physician

Surgery:

See Disease Characteristics
See Endocrine therapy
Recovered from prior surgery

Other:

No other prior or concurrent therapy for adenocarcinoma of the prostate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00004124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.