Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Luteinizing hormone-releasing hormone agonists may lessen the amount of androgens made by the body. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving luteinizing hormone-releasing hormone agonist together with an iodine I 125 implant may be an effective treatment for patients with prostate cancer. PURPOSE: This randomized phase III trial is studying how well giving luteinizing hormone-releasing hormone agonist therapy together with an iodine I 125 implant works with or without additional luteinizing hormone-releasing hormone agonist therapy in treating patients with previously untreated prostate cancer.

Timeline

Start

2008-04

Primary completion

2022-04-24

Completion

2023-06-30

Publications

• Results Miki K, Kiba T, Sasaki H, Kido M, Aoki M, Takahashi H, Miyakoda K, Dokiya T, Yamanaka H, Fukushima M, Egawa S. Transperineal prostate brachytherapy, using I-125 seed with or without adjuvant androgen deprivation, in patients with intermediate-risk prostate cancer: study protocol for a phase III, multicenter, randomized, controlled trial. BMC Cancer. 2010 Oct 21;10:572. doi: 10.1186/1471-2407-10-572.
• Urabe F, Miki K, Kimura T, Sasaki H, Tashiro K, Iwatani K, Matsukawa A, Aikawa K, Tsusumi Y, Morikawa M, Minato K, Sato S, Takahashi H, Aoki M, Egawa S. Long-term outcomes of radical prostatectomy versus low-dose-rate brachytherapy in patients with intermediate-risk prostate cancer: Propensity score matched comparison. Prostate. 2023 Feb;83(2):135-141. doi: 10.1002/pros.24445. Epub 2022 Sep 29.
• Tabata R, Kimura T, Kuruma H, Sasaki H, Kido M, Miki K, Takahashi H, Aoki M, Egawa S. Do androgen deprivation and the biologically equivalent dose matter in low-dose-rate brachytherapy for intermediate-risk prostate cancer? Cancer Med. 2016 Sep;5(9):2314-22. doi: 10.1002/cam4.820. Epub 2016 Jul 25.
• Sasaki H, Kido M, Miki K, Aoki M, Takahashi H, Dokiya T, Yamanaka H, Fukushima M, Egawa S. Results of central pathology review of prostatic biopsies in a contemporary series from a phase III, multicenter, randomized controlled trial (SHIP0804). Pathol Int. 2015 Apr;65(4):177-82. doi: 10.1111/pin.12260. Epub 2015 Feb 24.
• Sasaki H, Kido M, Miki K, Kuruma H, Takahashi H, Aoki M, Egawa S. Salvage partial brachytherapy for prostate cancer recurrence after primary brachytherapy. Int J Urol. 2014 Jun;21(6):572-7. doi: 10.1111/iju.12373. Epub 2013 Dec 23.
• Kimura T, Kido M, Miki K, Yamamoto T, Sasaki H, Kuruma H, Hayashi N, Takahashi H, Aoki M, Egawa S. Mid-term outcome of permanent prostate iodine-125 brachytherapy in Japanese patients. Int J Urol. 2014 May;21(5):473-8. doi: 10.1111/iju.12347. Epub 2013 Nov 20.

Drugs

Indications