Clinical trial · Interventional
Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer
NCT00020735CI-TRIAL-00020006completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using toremifene may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- oral toremifene
- interventionNames
- Drug: toremifene
- Procedure: neoadjuvant therapy
- type
- OTHER
- label
- observation
- interventionNames
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Percent of radical prostatectomy tissue volume (exclusive of luminal area) with high-grade prostatic intraepithelial neoplasia (HGPIN) present
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Organ-confined (cT1-2) disease (stage I or II) * Must be schedule to undergo radical prostatectomy * Prior sextant biopsy required PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * ALT and AST less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * No chronic hepatitis or cirrhosis Renal: * Creatinine less than 1.5 times ULN Other: * No severe mental or physical illness that would preclude radical prostatectomy * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * At least 5 years since prior antiestrogen, antiandrogen, LHRH agonist, estrogen, or progestational agent Radiotherapy: * Not specified Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.