Primary outcomeNumber· at 10 Years
Overall Survival
| Group | Value (percentage of probability of survival) |
|---|---|
| Arm I: Bicalutamide + Goserelin | 87 |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | 86 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataS9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
NCTNCT00004124 (opens ClinicalTrials.gov in a new tab)Other idCDR0000067352Other idS9921Other idCALGB-99904Other idU10CA032102
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 983 participants (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 15 Oct 1999
- Primary completion
- 12 Aug 2017
- Completion
- 1 May 2018
- First posted
- 27 Jan 2003 (estimated)
- Last update posted
- 30 Dec 2022
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2000200520102015
- Ph 3
S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
NCT0000412415 Oct 1999 to 1 May 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- bicalutamideDrug
- goserelinDrug
- mitoxantrone hydrochlorideDrug
- prednisoneDrug
Arms2
Active comparator
bicalutamide, goserelin
androgen deprivation
Experimental
bicalutamide, goserelin, mitoxantrone, prednisone
androgen deprivation plus mitoxantrone, prednisone
Primary outcomes2
Outcomes the sponsor listed as primary.
Overall Survival
Time frame · at 10 Years
Registry description
Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
Disease Free Survival
Time frame · at 10 Years
Registry description
Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.
Secondary outcomes(3)
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients
Time frame · Up to 22 months from registration
Registry description
Number of patients with adverse events that are related to study drug
PSA Progression Free Survival
Time frame · Up to 10 Years
Registry description
Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of \> 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.
PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival
Time frame · Up to 10 Years
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· at 10 Years
Disease Free Survival
| Group | Value (percentage of probability of survival) |
|---|---|
| Arm I: Bicalutamide + Goserelin | 72 |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | 72 |
Secondary and other outcome results(3)
Secondary outcomeNumber· Up to 22 months from registration
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients
| Group | Value (Participants) |
|---|---|
| Arm I: Bicalutamide + Goserelin | 19 |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | 41 |
Secondary outcome· Up to 10 Years
PSA Progression Free Survival
| Group | Value |
|---|---|
| Arm I: Bicalutamide + Goserelin | not posted |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | not posted |
Secondary outcome· Up to 10 Years
PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival
| Group | Value |
|---|---|
| Arm I: Bicalutamide + Goserelin | not posted |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Arm I: Bicalutamide + GoserelinPatients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity. | 85 / 469 | 3 / 469 | 461 / 469 |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + GoserelinPatients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone. | 91 / 460 | 11 / 460 | 457 / 460 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
More studies
2 studies on this page
Indexing hint: Randomized controlled trial · 2018
Corrected
Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921.
Hussain et al. 2018Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 37
PMID 29624463PMC5959197DOI 10.1200/jco.2017.76.4126PUB-29624463
Rights unknown
Indexing hint: Randomized controlled trial · 2011
Adjuvant androgen deprivation for high-risk prostate cancer after radical prostatectomy: SWOG S9921 study.
Dorff et al. 2011Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 71
PMID 21502546PMC3107759DOI 10.1200/jco.2010.32.2776PUB-21502546
Rights unknown
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultGlode LM, Tangen CM, Hussain MH, et al.: Southwest Oncology Group S9921: prolonged event-free survival in high-risk prostate cancer (PC) patients receiving adjuvant androgen deprivation. [Abstract] J Clin Oncol 27 (Suppl 15): A-5009, 2009.
- ResultFlaig TW, Tangen CM, Hussain MH, Stadler WM, Raghavan D, Crawford ED, Glode LM; Southwest Oncology Group. Randomization reveals unexpected acute leukemias in Southwest Oncology Group prostate cancer trial. J Clin Oncol. 2008 Mar 20;26(9):1532-6. doi: 10.1200/JCO.2007.13.4197. PMID 18349405
- ResultGlode LM, Hussain MH, Benson MC, et al.: SWOG 9921: a phase III multi-institutional trial of adjuvant therapy for high risk prostate cancer after radical prostatectomy. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-349, 2007.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 120 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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