Clinical trial · Interventional
Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone With IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk 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. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have 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 |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| bicalutamide | Drug | Bicalutamide | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMRT alone to 86.4 Gy
- description
- External radiotherapy is given for 10 weeks, Monday through Friday for a total of 48 sessions. The total dose of radiotherapy delivered during these 10 weeks is 86.4 Gy. The radiation treatments are delivered with a high precision technique called intensity modulated radiotherapy or IMRT. For this treatment, no hormonal therapy is required.
- interventionNames
- Procedure: assessment of therapy complications
- Procedure: quality-of-life assessment
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- IMRT TO 75.6 Gy plus Adjuvant Androgen Deprivation
- description
- Prior to a planned course of radiotherapy, which will last for eight and a half weeks, 10 weeks of hormonal therapy are given. The hormonal therapy will start with a daily pill called Casodex. Three to seven days after starting this pill, a Zoladex injection will be administered in addition to the Casodex pill. Zoladex hormonal therapy is given in the form of a monthly injection. After 10 weeks from the initiation of hormone therapy, you will begin external radiotherapy. For these treatments only 42 treatment sessions are given. The total dose of radiotherapy delivered during these 8.5 weeks is 75.6 Gy. The hormone injections continue during the radiation treatments and for 2 years after the radiation treatments. The pills are only taken for the 10 weeks before and also during the radiation treatments, however afterwards the pills are discontinued.
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 * Unfavorable-risk disease, including at least 2 of the following characteristics: * Prostate-specific antigen level greater than 10 ng/mL * Gleason score greater than 7 * Stage T4 * Intermediate-risk disease with a Gleason score of at least 8 allowed * Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection * Prostate size less than 75 grams * No distant metastases by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 1.5 times ULN Renal * Not specified Other * No documented history of inflammatory bowel disease * No bilateral hip replacements * No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years * No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for prostate cancer Endocrine therapy * No prior androgen-deprivation therapy Radiotherapy * No prior pelvic radiotherapy * No prior prostate brachytherapy Surgery * No prior bilateral orchiectomy * No prior radical prostatectomy * No prior cryotherapy for prostate cancer
References
Publications (0)
Data not yet available