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

NCT00664456 | Completed Phase 3 DMC

• 2 other identifiers: BRIGU05-01CDR0000593653
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; stage I prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Overall survival (OS)

  13.5 years

• Clinical progression-free survival

  7 years

• Disease-specific survival

  7 years

• Salvage therapy non-adaptive interval

  7 years

• Quality of life (QOL) evaluation

  Baseline and Month 60 after TPPB

Study Arms (2)

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).

Drug: Adjuvant therapy; Drug: Neoadjuvant therapy; Radiation: Brachytherapy（iodine I 125）

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.

Drug: Neoadjuvant therapy; Radiation: Brachytherapy（iodine I 125）

Interventions

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).

AHT group

Neoadjuvant therapy DRUG

3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).

AHT group; Non-AHT group

Brachytherapy（iodine I 125） RADIATION

Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).

AHT group; Non-AHT group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• The Jikei University School of Medicine: collaborator

Study Sites (1)

The Jikei University School of Medicine

Tokyo, 125-8506, Japan

Location

Related Publications (6)

• 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.

  PMID: 20964826 RESULT

• 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.

  PMID: 36176043 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.

  PMID: 27456710 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.

  PMID: 25707702 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.

  PMID: 24372730 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.

  PMID: 24256329 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Shin Egawa, MD, PhD

  The Jikei University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: April 24, 2022
• Study Completion: June 30, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

JP (1)