drugset / Trial / NCT00002633
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Phase 3
Completed
361 enrolled
NCIC Clinical Trials Group
Eastern Cooperative Oncology Group · collabMedical Research Council · collabNational Cancer Institute (NCI) · collabSWOG Cancer Research Network · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 1995-02-08
- Primary completion
- 2011-09-23
- Completion
- 2012-01-06
Publications
- Results Warde 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.
- Brundage 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.
- Mason 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Comparator | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Comparator | Goserelin | Other / unclassified | 10.8 mg | Subcutaneous |
| Comparator | Leuprolide | Other / unclassified | 7.5 mg | Intramuscular |
| Comparator | Leuprolide | Other / unclassified | 22.5 mg | Intramuscular |
| Comparator | Leuprolide | Other / unclassified | 30 mg | Intramuscular |
| Comparator | Nilutamide | Small molecule | 100 mg | Oral |
| Comparator | Nilutamide | Small molecule | 150 mg | Oral |
| Comparator | buserelin | Unknown | 6.3 mg | Subcutaneous |
| Comparator | buserelin | Unknown | 9.45 mg | Subcutaneous |
| Comparator | flutamide | Small molecule | 250 mg | Oral |