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

Prostate Cancer Clinical Trial

— SHIP0804  

Official title:

A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-agonist Therapy in Patients With Untreated Intermediate-risk Prostate Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664456
• Other study ID #: BRIGU05-01
• Secondary ID: CDR0000593653
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: June 30, 2023
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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).

Radiation:
• Brachytherapy(iodine I 125)
Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).

Locations

Country	Name	City	State
Japan	The Jikei University School of Medicine	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	The Jikei University School of Medicine

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 prostat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	Interval from the 1st day of treatment to the earliest day of death any reason.	13.5 years
Secondary	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.	7 years
Secondary	Disease-specific survival	Interval from the 1st day of treatment to death caused by prostate cancer	7 years
Secondary	Salvage therapy non-adaptive interval	Observational term as salvage therapy non-adaptive interval.	7 years
Secondary	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
Secondary	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