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

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.

Sex

Male

Minimum age

20 Years

Maximum age

75 Years

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed prostate cancer

  * Previously untreated disease
* Intermediate-risk disease, as defined by the following:

  * Clinical stage \< T2c
  * Prostate-specific antigen (PSA) ≤ 20 ng/mL
  * Gleason score \< 8

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Leukocyte count ≥ 3,000/uL
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/uL
* Serum creatinine ≤ 2.0 mg/dL
* ALT and AST ≤ 100 IU/L
* No other cancer requiring treatment
* No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
* No severe psychiatric disorders, including schizophrenia or dementia
* No poorly controlled diabetes
* Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

* No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
* No prior surgery for prostate cancer
* No concurrent steroid drugs (except for ointment)
* No other concurrent antiandrogen therapy

• RESULTMiki 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. PMID 20964826
• DERIVEDUrabe 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. PMID 36176043
• DERIVEDTabata 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. PMID 27456710
• DERIVEDSasaki 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. PMID 25707702
• DERIVEDSasaki 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. PMID 24372730
• DERIVEDKimura 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.