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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000593653 | Other Identifier | National Cancer Institute |
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| Name | Class |
|---|---|
| The Jikei University School of Medicine | UNKNOWN |
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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.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHT group | Active Comparator | Randomized patients undergo 3-month neoadjuvant therapy (NHT)within 14 days and receive 9-month adjuvant therapy (AHT) following after Iodine I-125 implantation (TPPB). |
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| Non-AHT group | Active Comparator | Rondomized patients undergo 3-month neoadjuvant therapy (NHT) within 14 days and receive Iodine I-125 implantation therapy (TPPB). 40 weeks observation is followed under no further treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant therapy | Drug | AHT group receives 9 cycle of LHRH-A (goserelin acetate 3.6 mg/4 weeks or leuprorelin acetate 3.75 mg/4 weeks) after Iodine I-125 implantation (TPPB). |
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| Measure | Description | Time Frame |
|---|---|---|
| Biochemical progression-free survival (bPFS) | Interval from the 1st day of treatement to the earliest day on which confirmation of increase in prostate specific antigen (PSA) or death any reason. | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Interval from the 1st day of treatment to the earliest day of death any reason. | 13.5 years |
| Clinical progression-free survival | Interval from the 1st day of treatment to the ealiest day on which identification of desease progression or death for any reason. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prostate cancer
Intermediate-risk disease, as defined by the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Shin Egawa, MD, PhD | The Jikei University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jikei University School of Medicine | Tokyo | 125-8506 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20964826 | Result | 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. | |
| 36176043 |
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| Neoadjuvant therapy | Drug | 3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks). |
|
| Brachytherapy(iodine I 125) | Radiation | Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB). |
|
| 7 years |
| Disease-specific survival | Interval from the 1st day of treatment to death caused by prostate cancer | 7 years |
| Salvage therapy non-adaptive interval | Observational term as salvage therapy non-adaptive interval. | 7 years |
| Quality of life (QOL) evaluation | QOL assesed by the Japanese version of the SF-8 (the MOS 8 item Short-Form Health Survey), the Japanese version of the Expanded Prostate Cancer Index Composite (EPIC), and the International Prostate Sympton Score (IPSS). | Baseline and Month 60 after TPPB |
| Adverse events (AE) | The incident propotion of adverse event grade above 3 by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0) will be compared. | AE to androgen-deprivation therapy (ADT) within 24 month, AE to 125I-transperineal prostatic brachytherapy (TPPB) within 36 month of the therapy |
| Derived |
| 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. |
| 27456710 | Derived | 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. |
| 25707702 | Derived | 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. |
| 24372730 | Derived | 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. |
| 24256329 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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