Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer
NCT ID: NCT00664456
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2008-04-30
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer
NCT00898326
External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
NCT00006365
Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer
NCT01813097
Brachytherapy in Treating Patients With Prostate Cancer
NCT00003312
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy
NCT00175396
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* To evaluate the biochemical progression-free survival (PFS), overall survival, clinical PFS, and disease-free survival of patients with previously untreated intermediate-risk prostate cancer treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist therapy and permanent iodine I 125 implantation with vs without adjuvant LHRH agonist therapy.
* To determine the non-adaptive interval to salvage therapy in patients treated with these regimens.
* To determine the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive neoadjuvant luteinizing hormone-releasing hormone (LHRH) agonist therapy for up to 3 months and undergo permanent iodine I 125 implantation. Patients then receive adjuvant LHRH agonist therapy for up to 9 months.
* Arm II: Patients receive neoadjuvant LHRH agonist therapy and undergo permanent iodine I 125 implantation as in arm I.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AHT group
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).
Adjuvant therapy
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).
Neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
Brachytherapy（iodine I 125）
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
Non-AHT group
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.
Neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
Brachytherapy（iodine I 125）
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adjuvant therapy
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).
Neoadjuvant therapy
3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).
Brachytherapy（iodine I 125）
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
20 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Jikei University School of Medicine
UNKNOWN
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shin Egawa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Jikei University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Jikei University School of Medicine
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000593653
Identifier Type: OTHER
Identifier Source: secondary_id
BRIGU05-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.