Clinical trial · Interventional
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized 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: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with 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 |
|---|---|---|---|
| flutamide | Drug | Flutamide | ALIAS |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven localized adenocarcinoma of the prostate * Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4 * CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50 * Negative pelvic lymphadenectomy, if PSA is greater than 50 * Bone scan negative for metastases or PSA no greater than 20 PATIENT CHARACTERISTICS: Age: * Not specified Performance Status: * Not specified Life Expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 70,000/mm3 * Hemoglobin at least 10 g/dL * Patients on anticoagulant therapy must have a baseline PT test Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * ALT or AST less than 1.5 times ULN * Alkaline phosphatase less than 1.5 times ULN Renal: * Creatinine less than 1.5 times ULN Cardiovascular: * No history of collagen vascular disease Other: * No acute infection requiring antibiotics * No history of hypersensitivity to flutamide * No history of hypersensitivity to leuprolide acetate PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (1)
- RESULTHeymann JJ, Benson MC, O'Toole KM, Malyszko B, Brody R, Vecchio D, Schiff PB, Mansukhani MM, Ennis RD. Phase II study of neoadjuvant androgen deprivation followed by external-beam radiotherapy with 9 months of androgen deprivation for intermediate- to high-risk localized prostate cancer. J Clin Oncol. 2007 Jan 1;25(1):77-84. doi: 10.1200/JCO.2005.05.0419. PMID 17194907