SHIP0804

JRCT ID: jRCTs031180256

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 13/03/2019
• Target sample size: 420
• Study type: Interventional

Intervention(s)

1.Endocrine therapy before brachytherapy treatment ( neoadjuvant hormone therapy ( NHT ) )
LHRH - A ( Goserelin acetate Zoladex 3.6 mg / 4 weeks, or leuprorelin acetate Leuprin 3.75 mg / 4 weeks ) is administered three times.
1) The first endocrine therapy will be carried out within 14 days after registration.
2) A second endocrine therapy is performed within 4 to 5 weeks from the first endocrine therapy.
3)Third endocrine therapy is performed within 4 to 5 weeks from the second endocrine therapy.

2.Brachytherapy
From the third endocrine therapy practice, brachytherapy should be performed within 4 to 6 weeks.

Non-AHT group
3.Follow-up observation after inserting a small radiation source

AHT group
3.Endocrine therapy after insertion of brachytherapy (Adjuvant hormone therapy (AHT) )
For cases of AHT group, LHRH - A (goserelin acetate Zoladex 3.6 mg / 4 weeks, or leuprorelin acetate: Leuprin 3.75 mg / 4 weeks) is administered nine times after brachytherapy.
1) .Fourth endocrine therapy will be performed within 4 to 5 weeks (total from NHT) after insertion of the brachytherapy source.
2) (Total from NHT) Fifth endocrine therapy is performed within 4 to 5 weeks (total from NHT) from the 4th endocrine therapy.
3) Thereafter, endocrine therapy is carried out every 4 to 5 weeks until the twelfth endocrine therapy (totaling from NHT) likewise.

Outcome(s)

Primary Outcome

The primary endpoint is biochemical progression-free survival (BPFS).
Protocol From the date of treatment start, the date of examination (blood collection day) recognized as recurrence of PSA, the day of death due to any cause, the point of relief therapy adaptation (relief therapy start date) when some remedy is applied before PSA recurrence , The period until the earliest one.
In surviving cases that are not judged as recurrence, we will terminate midway with the final PSA examination date.

Secondary Outcome

1.Overall survival
Protocol The period from the treatment start date to the death date due to any cause.
1.In the survival example, it is assumed that the final survival confirmation date is aborted.
2.In the case of non-traceable example, it is assumed that the last survival confirm date before becoming non-traceable is aborted halfway.

2.Clinical non-recurrence survival period
From the protocol treatment starting date, the examination date recognized as clinical recurrence, or the death date due to any cause, whichever comes earlier. In addition, clinical non-recurrence cases and untraceable cases, the term will be terminated halfway on the final survival confirmation date.

3.Disease specific survival time
Protocol From the treatment start date to the date of death of prostate cancer death.
1.In the case of survival, non-traceable cases, it is considered to be aborted with a final survival confirmation date.
2.Deaths other than prostate cancer death shall be terminated midway with the death confirmation date.

4.Salvage therapy non-adaptive period:
From the protocol treatment starting date, salvage therapy is not performed and the follow-up observation is continued.
1)In case of death without receiving salvage therapy, the term will be terminated on the day of death.
2)If you survive without receiving salvage therapy, make halfway stop at the final confirmation date of the presence or absence of salvage therapy. However, if the final confirmation date for the presence or absence of salvage therapy is unknown, it will be terminated at the final survival confirmation date.
3)If it becomes untraceable without receiving salvage therapy, the term will be terminated halfway on the final confirmation date of the presence or absence of salvage therapy. However, if the final confirmation date for the presence or absence of salvage therapy is unknown, it will be terminated at the final survival confirmation date.

5.QOL evaluation
Evaluate based on the QOL questionnaire (SF8, EPIC, IPSS).

6.Adverse event occurrence rate
The proportion of cases that developed adverse events of NCI - CTCAE Grade 3 or higher in each treatment group.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Male

Include criteria

1.Prostate cancer classified as an intermediate risk group from clinical stage, PSA value, Gleason score of central pathology diagnosis.
2. Be previously untreated Pca.
3. ECOG PS is 0 or 1
4.The age at consent acquisition is between 20 years old and 75 years old.
5.Laboratory test values satisfy the following criteria.
1) White blood cell count over 3000 / myu L
2) Hemoglobin over 10.0 g / dL
3) Number of platelets over 100000 / myu L
4) Serum creatinine under 2.0 mg / dL
5) AST (GOT) under 100 IU / L
6) ALT (GPT) under 100 IU / L
6. Agree in writing to participate in this clinical study after receiving adequate explanation.

Exclude criteria

1. Have PSA over 20 ng/mL.
2. Have a biopsy Gleason score over 8.
3. Exhibit clinical stage over T2c.
4. Have a second cancer that requires treatment.
5. Have poorly-controlled hypertension (diastolic pressure over 120mmHg)
6. Have a severe psychiatric disorder, including schizophrenia and dementia.
7. Have collagen disease diabetes.
8. Have poorly-controlled diabetes.
9. Have previously received surgery for PCa.
10. Are using steroid drugs other than topical ointments.
11. Are using antiandrogenic therapy.
12. Are for any other reason considered by a Principal Investigator or Clinical Investigator to be inappropriate for participation in the present study.

Related Information

• Primary Sponsor: Egawa Shin
• Source(s) of Monetary Support: Nihon Medi-Physics Co.,Ltd.
• Secondary ID(s): NCT00664456