Clinical trial · Interventional
Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.) PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| bicalutamide | Drug | Bicalutamide | ALIAS |
| flutamide | Drug | Flutamide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| releasing hormone agonist therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- LH-RH agonist plus radiation therapy
- description
- Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
- interventionNames
- Drug: bicalutamide
- Drug: flutamide
- Drug: releasing hormone agonist therapy
- Procedure: adjuvant therapy
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Radiation therapy alone
- description
- Radiation therapy alone to 63.0 - 66.6 Gy
- interventionNames
- Procedure: adjuvant therapy
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 0 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * T2-3, N0, M0 * No metastatic disease * High-risk for PSA relapse as defined by Gleason score 7 or higher and ≥ 1 of the following OR Gleason score \< 7 and ≥ 2 of the following: * Preoperative PSA \> 10 ng/mL * Positive surgical margins * Seminal vesicle invasion * Preoperative PSA ≤ 40.0 ng/mL * Postoperative PSA ≤ 0.2 ng/mL * Negative lymph node status by lymph node sampling or dissection * If lymph node status is unknown, must have \< 5% risk of involvement by Roach formula PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 130,000/mm\^3 * Hemoglobin ≥ 11.4 g/dL Hepatic: * ALT ≤ 3 times normal Renal: * Creatinine ≤ 2.5 mg/dL Other: * No other prior or concurrent invasive malignancy within the past 5 years except superficial nonmelanoma skin cancer * No other major medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 5 years since prior chemotherapy Endocrine therapy: * At least 60 days since prior finasteride * At least 90 days since prior testosterone * Prior pharmacologic androgen ablation for prostate cancer allowed if initiated within the past 10 months (must switch to study ablation therapy OR discontinue therapy if randomized to receive radiotherapy only) Radiotherapy: * No prior radiotherapy to the pelvis * No concurrent intensity-modulated radiotherapy Surgery: * No prior orchiectomy
References
Publications (0)
Data not yet available