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Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer (SHIP0804)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Adjuvant therapy

Neoadjuvant therapy

Brachytherapy（iodine I 125）

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage I prostate cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

The Jikei University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

AHT group

Non-AHT group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival (OS)

Interval from the 1st day of treatment to the earliest day of death any reason.

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.

Disease-specific survival

Interval from the 1st day of treatment to death caused by prostate cancer

Salvage therapy non-adaptive interval

Observational term as salvage therapy non-adaptive interval.

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).

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.

Full Information

NCT ID

NCT00664456

First Posted

April 22, 2008

Last Updated

July 21, 2023

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

The Jikei University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00664456

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 2008 (Actual)

Primary Completion Date

April 24, 2022 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

The Jikei University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

stage IIB prostate cancer, stage IIA prostate cancer, stage I prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

421 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AHT group

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Non-AHT group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Adjuvant therapy

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Neoadjuvant therapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Brachytherapy（iodine I 125）

Intervention Description

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

Primary Outcome Measure Information:

Title

Biochemical progression-free survival (bPFS)

Description

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.

Time Frame

7 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Interval from the 1st day of treatment to the earliest day of death any reason.

Time Frame

13.5 years

Title

Clinical progression-free survival

Description

Interval from the 1st day of treatment to the ealiest day on which identification of desease progression or death for any reason.

Time Frame

7 years

Title

Disease-specific survival

Description

Interval from the 1st day of treatment to death caused by prostate cancer

Time Frame

7 years

Title

Salvage therapy non-adaptive interval

Description

Observational term as salvage therapy non-adaptive interval.

Time Frame

7 years

Title

Quality of life (QOL) evaluation

Description

Time Frame

Baseline and Month 60 after TPPB

Title

Adverse events (AE)

Description

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.

Time Frame

AE to androgen-deprivation therapy (ADT) within 24 month, AE to 125I-transperineal prostatic brachytherapy (TPPB) within 36 month of the therapy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shin Egawa, MD, PhD

Organizational Affiliation

The Jikei University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Jikei University School of Medicine

City

Tokyo

ZIP/Postal Code

125-8506

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

20964826

Citation

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.

Results Reference

result

PubMed Identifier

27456710

Citation

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.

Results Reference

derived

PubMed Identifier

25707702

Citation

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.

Results Reference

derived

PubMed Identifier

24372730

Citation

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.

Results Reference

derived

PubMed Identifier

24256329

Citation

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.

Results Reference

derived

Learn more about this trial

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

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