Clinical trial · Interventional
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate
- 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: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| buserelin | Drug | Buserelin | ALIAS |
| flutamide | Drug | Flutamide | ALIAS |
| goserelin | Drug | Goserelin | ALIAS |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| nilutamide | Drug | Nilutamide | ALIAS |
| orchiectomy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Total Androgen Blockade
- interventionNames
- Drug: bicalutamide
- Drug: buserelin
- Drug: flutamide
- Drug: goserelin
- Drug: leuprolide acetate
- Drug: nilutamide
- Procedure: orchiectomy
- type
- ACTIVE_COMPARATOR
- label
- Total Androgen Blockade Vs TA Blockade Plus Pelvic Irradiation
- interventionNames
- Drug: bicalutamide
- Drug: buserelin
- Drug: flutamide
- Drug: goserelin
- Drug: leuprolide acetate
- Drug: nilutamide
- Procedure: orchiectomy
- Radiation: radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 79 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following: * T3-4, N0 or NX, M0 * T2, PSA greater than 40 µg/L * T2, PSA greater than 20 µg/L AND Gleason score at least 8 * Diagnosis made within the past 6 months * Gleason score and PSA known * Pelvic lymph nodes must be clinically negative * Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis * Negative needle aspirate required for any lymph node more than 1.5 cm * If a lymph node dissection was performed, it must be histologically negative * No small cell or transitional cell carcinoma by biopsy * No bony metastases by bone scan PATIENT CHARACTERISTICS: Age: * Under 80 Performance status: * ECOG 0-2 Life expectancy: * At least 5 years excluding malignancy Hematopoietic: * Hemoglobin at least 10.0 g/dL * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT and SGPT less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * No history of chronic liver disease Renal: * Creatinine less than 2 times ULN Other: * No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability) * No other malignancy within the past 5 years except nonmelanoma skin cancer * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met: * Negative bone scan before beginning any hormonal therapy * Extracapsular extension remains palpable on rectal re-exam * Baseline PSA known before beginning any hormonal therapy * At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy Radiotherapy: * No prior pelvic irradiation Surgery: * No prior radical prostatectomy * Prior transurethral resection of the prostate allowed Other: * No prior cytotoxic anticancer therapy * No other prior treatment for prostate cancer * No other concurrent anticancer therapy unless documented disease progression
References
Publications (3)
- RESULTWarde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W; NCIC CTG PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2. PMID 22056152
- DERIVEDBrundage M, Sydes MR, Parulekar WR, Warde P, Cowan R, Bezjak A, Kirkbride P, Parliament M, Moynihan C, Bahary JP, Parmar MK, Sanders K, Chen BE, Mason MD. Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial. J Clin Oncol. 2015 Jul 1;33(19):2151-7. doi: 10.1200/JCO.2014.57.8724. Epub 2015 May 26. PMID 26014295
- DERIVEDMason MD, Parulekar WR, Sydes MR, Brundage M, Kirkbride P, Gospodarowicz M, Cowan R, Kostashuk EC, Anderson J, Swanson G, Parmar MK, Hayter C, Jovic G, Hiltz A, Hetherington J, Sathya J, Barber JB, McKenzie M, El-Sharkawi S, Souhami L, Hardman PD, Chen BE, Warde P. Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer. J Clin Oncol. 2015 Jul 1;33(19):2143-50. doi: 10.1200/JCO.2014.57.7510. Epub 2015 Feb 17. PMID 25691677