Clinical trial · Interventional
S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| estramustine | Drug | Estramustine | ALIAS |
| mitoxantrone | Drug | Mitoxantrone | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel and Estramustine
- description
- Estramustine, 280 mg, PO, TID, Days 1-5; q 21 days Docetaxel, 60mg/m2, IV, Day 2; q 21 days
- interventionNames
- Drug: docetaxel
- Drug: estramustine
- type
- ACTIVE_COMPARATOR
- label
- Mitoxantrone and Prednisone
- description
- Mitoxantrone, 12 mg/m2, IV, Day 1; q 21 days Prednisone, 5 mg, PO, BID, Days 1-21; q 21 days
- interventionNames
- Drug: mitoxantrone
- Drug: prednisone
Primary outcomes (1)
- measure
- Compare overall survival in the two study arms
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the prostate * Unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: * Progression of bidimensionally measurable disease * Progression of evaluable but not measurable disease (bone scan) * At least 2 consecutive rises in PSA and a PSA level of at least 5 ng/mL * No minimum PSA required for measurable disease or non-PSA evaluable disease * Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease * Prior orchiectomy OR * Medical castration using leuprolide or goserelin * Luteinizing hormone-releasing hormone (LHRH) agonist therapy must continue during study * Prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred * No third-space fluid accumulation such as ascites or symptomatic pleural effusion * No brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-3 * Performance status 3 must be due to pain secondary to bone metastases Life expectancy: * Not specified Hematopoietic: * No hypercoagulability Hepatic: * Not specified Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No history of myocardial infarction * No history of congestive heart failure unless well controlled * No history of cerebrovascular accident or atrial fibrillation * No active thrombophlebitis * Left ventricular ejection fraction (LVEF) at least 50% by Multi Gated Acquisition Scan (MUGA) scan or 2-D echocardiogram Pulmonary: * No history of pulmonary embolus Other: * Recovered from major infections * No other significant active medical illness * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy and recovered * No more than 1 prior biologic therapy regimen * No concurrent biological response modifiers Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered * No more than 1 prior chemotherapy regimen * No prior estramustine, taxanes, anthracyclines, or mitoxantrone * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior flutamide or ketoconazole (6 weeks for bicalutamide or nilutamide) * No concurrent corticosteroids or hormonal therapy (except megestrol for hot flashes or continuing LHRH treatment) Radiotherapy: * See Disease Characteristics * Prior samarium Sm 153 lexidronam pentasodium allowed * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to 30% or more of bone marrow * No prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 3 weeks since prior surgery and recovered Other: * At least 4 weeks since prior bisphosphonates * No prior anticoagulation therapy (i.e., warfarin), except aspirin * No concurrent bisphosphonates
References
Publications (21)
- BACKGROUNDHussain M, Goldman B, Tangen C, Higano CS, Petrylak DP, Wilding G, Akdas AM, Small EJ, Donnelly BJ, Sundram SK, Burch PA, Dipaola RS, Crawford ED. Prostate-specific antigen progression predicts overall survival in patients with metastatic prostate cancer: data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol. 2009 May 20;27(15):2450-6. doi: 10.1200/JCO.2008.19.9810. Epub 2009 Apr 20. PMID 19380444
- BACKGROUNDde Wit R. Chemotherapy in hormone-refractory prostate cancer. BJU Int. 2008 Mar;101 Suppl 2:11-5. doi: 10.1111/j.1464-410X.2007.07485.x. PMID 18307687
- BACKGROUNDGoldman B, Hussain M, Tangen C, et al.: Prostate-specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-165, 2008.
- BACKGROUNDHussain MH, Goldman B, Tangen CM, et al.: Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] J Clin Oncol 26 (Suppl 15): A-5015, 2008.
- BACKGROUNDCalabro F, Sternberg CN. Current indications for chemotherapy in prostate cancer patients. Eur Urol. 2007 Jan;51(1):17-26. doi: 10.1016/j.eururo.2006.08.013. Epub 2006 Aug 22. PMID 17007996
- BACKGROUNDChowdhury S, Burbridge S, Harper PG. Chemotherapy for the treatment of hormone-refractory prostate cancer. Int J Clin Pract. 2007 Dec;61(12):2064-70. doi: 10.1111/j.1742-1241.2007.01551.x. Epub 2007 Oct 23. PMID 17956560
- BACKGROUNDMendiratta P, Armstrong AJ, George DJ. Current standard and investigational approaches to the management of hormone-refractory prostate cancer. Rev Urol. 2007;9 Suppl 1(Suppl 1):S9-S19. PMID 17387372