SHIP36B

JRCT ID: jRCTs031180274

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 14/03/2019
• Target sample size: 309
• Study type: Interventional

Intervention(s)

Prostate needle biopsy is performed at 36-39 months after insertion of the small radiation source.
Biopsy method is basically transrectal ultrasound guided systematic biopsy.
Six systematic biopsies and two seminal vesicles on the left and right as far as possible.

Outcome(s)

Primary Outcome

The group of patients who had been diagnosed prostate cancer by prostatic biopsy 36 months after seed implantation is defined as "radiation ineffective group", and the group that had not been diagnosed prostate cancer is defined as "radiation effective group", and these are abbreviated as "radiation group". Undeterminable cases are included in the radiation ineffective group. Further, the AHT group and the non-AHT group are referred to as the treatment group.
As a primary outcome, biochemical recurrent free survival by the following definition is compared between radiation groups. Comparison between radiation groups is performed for each treatment group (stratified analysis). However, when the number of patients in the radiation ineffective group is 10 or less, this stratified analysis is not performed, and only comparisons between the radiation groups are performed.
Definition:
The period up to the earliest from either one from following cases. The period between PSA examination date recognized as PSA recurrence and seed implantation date, the date of death due to any cause, or salvage therapy starting date when some treatment is applied before the PSA recurrence. In the survival case which has not been judged to be a recurrence, it is terminated by the last PSA examination date.

Secondary Outcome

1)Overall survival
Overall survival as defined below is compared between radiation groups. The comparison between the radiation groups will be performed stratified by the treatment group. However, if the number of patients in the radiation-ineffective group is 10 or less, stratified analysis will not be performed.
Definition:
The period from the start date of protocol treatment to the date of death due to any cause. In addition, in the case of surviving cases, the term will be terminated halfway on the final survival confirmation date. In untraceable cases, the final survival confirmation date before the follow-up becomes untraceable will be discontinued.
2)Clinical non-recurrence survival time
The clinical non-recurrence survival time as defined below is compared between radiation groups. The comparison between the radiation groups will be performed stratified by the treatment group. However, if the number of patients in the radiation-ineffective group is 10 or less, stratified analysis will not be performed. In addition, the definition of clinical recurrence follows the description in the SHIP0804 study protocol.
Definition:
The period from the start date of protocol treatment to the date of examination recognized as clinical recurrence or the date of death due to any cause, whichever comes earlier. Survival cases and untraceable cases with no clinical recurrence shall be the period until the final survival confirmation date.
3)Disease-specific survival time
Disease-specific survival times as defined below are compared between radiation groups. The comparison between the radiation groups will be performed stratified by the treatment group. However, if the number of patients in the radiation-ineffective group is 10 or less, stratified analysis will not be performed.
Definition:
The period from the start date of protocol treatment to the date of death from prostate cancer. In addition, for surviving cases and untraceable cases, the term will be terminated halfway on the final survival confirmation date. Deaths other than prostate cancer death will be discontinued on the date of confirmation of death.
4)Salvage therapy non-adaptive period
The duration of salvage therapy non-adaptation as defined below is compared between radiation groups. The comparison between the radiation groups will be stratified by the treatment group. However, if the number of patients in the radiation-ineffective group is 10 or less, stratified analysis will not be performed.
Definition:
From the start date of protocol treatment, the period during which salvage therapy was not performed and follow-up was continued. If the patient dies without receiving salvage therapy, the procedure will be terminated on the day of death. Patients and untraceable patients who survive without salvage therapy will be censored on the final confirmation date for salvage therapy. However, if the final confirmation date for the presence or absence of salvage therapy is unknown, it will be terminated on the final survival confirmation date.
5)PSA velocity
Compare the degree of increase in PSA between radiation groups during the period from the lowest PSA value to just before the biopsy. PSA velocity = (PSA value at the time of the test closest to the biopsy date-PSA nadir value) / (Test date closest to the biopsy date-PSA nadir measurement date + 1). However, patients without a record of these PSA levels are excluded from the analysis. The comparison between the radiation groups will be stratified in the treatment group. However, if the number of patients in the radiation-ineffective group is 10 or less, stratified analysis will not be performed.
6)Brachytherapy information:
Compare the number of sources, V100, D90, and bioequivalent dose (BED) between radiation groups. The comparison between the radiation groups will be stratified in the treatment group. However, if the number of patients in the radiation-ineffective group is 10 or less, stratified analysis will not be performed.

Key inclusion & exclusion criteria

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

Include criteria

1. be enrolled to SHIP0804 study.
2. be treated with trans-perineal prostate brachytherapy.
3. have the documented informed consent before SHIP0804.
4. have the documented informed consent before the protocol biopsy at 36 months after brachytherapy.

Exclude criteria

1. have been diagnosed as any PSA recurrence or clinical recurrence before the protocol biopsy at 36 months after brachytherapy.
2. be inappropriate for participation in the present study for any other reason considered by a principal investigator or clinical investigator of this study.

Related Information

• Primary Sponsor: Egawa Shin
• Source(s) of Monetary Support: Nihon Medi-Physics Co.,Ltd.
• Secondary ID(s): NCT00898326