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Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Adjuvant Androgen-Deprivation Therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring localized, High risk, Prostate Cancer, Randomized, Cryotherapy, Cryoablation, Adjuvant, Androgen Deprivation Therapy, Hormone therapy, ADT

Eligibility Criteria

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

Inclusion Criteria:

Age>20 years
Histopathology proven prostate adenocarcinoma
Non-metastatic localized disease
Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible.
Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed.
Subjects are willing to sign the informed consent and agree to comply with the study procedures

Exclusion Criteria:

Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
Other conditions the investigators think may affect subject compliance or safety

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant Androgen-Deprivation Therapy

No adjuvant therapy

Arm Description

Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy

Cryotherapy without any adjuvant therapy

Outcomes

Primary Outcome Measures

A composite trifecta endpoint of treatment failure at 3 years after cryoablation

A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.

Secondary Outcome Measures

Time to the composite endpoint of treatment failure since cryoablation

Biochemical (PSA) recurrence rate at 3 years

Biochemical (PSA) recurrence-free survival

Biopsy-proven recurrence rate at 3 years

Biopsy-proven recurrence-free survival

Safety profile

Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.

Full Information

NCT ID

NCT01398657

First Posted

July 14, 2011

Last Updated

November 13, 2012

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01398657

Brief Title

Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

Official Title

Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.

Detailed Description

Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.

6. Conditions and Keywords

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

Prostate Cancer

Keywords

localized, High risk, Prostate Cancer, Randomized, Cryotherapy, Cryoablation, Adjuvant, Androgen Deprivation Therapy, Hormone therapy, ADT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adjuvant Androgen-Deprivation Therapy

Arm Type

Experimental

Arm Description

Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy

Arm Title

No adjuvant therapy

Arm Type

No Intervention

Arm Description

Cryotherapy without any adjuvant therapy

Intervention Type

Drug

Intervention Name(s)

Adjuvant Androgen-Deprivation Therapy

Other Intervention Name(s)

Adjuvant hormone therapy

Intervention Description

Short-term adjuvant androgen-deprivation therapy

Primary Outcome Measure Information:

Title

A composite trifecta endpoint of treatment failure at 3 years after cryoablation

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Time to the composite endpoint of treatment failure since cryoablation

Description

Time to the composite endpoint of treatment failure since cryoablation

Time Frame

3 years

Title

Biochemical (PSA) recurrence rate at 3 years

Description

Biochemical (PSA) recurrence rate at 3 years

Time Frame

3 years

Title

Biochemical (PSA) recurrence-free survival

Description

Biochemical (PSA) recurrence-free survival

Time Frame

3 years

Title

Biopsy-proven recurrence rate at 3 years

Description

Biopsy-proven recurrence rate at 3 years

Time Frame

3 years

Title

Biopsy-proven recurrence-free survival

Description

Biopsy-proven recurrence-free survival

Time Frame

3 years

Title

Safety profile

Description

Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age>20 years Histopathology proven prostate adenocarcinoma Non-metastatic localized disease Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c) Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible. Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed. Subjects are willing to sign the informed consent and agree to comply with the study procedures Exclusion Criteria: Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening. Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin Other conditions the investigators think may affect subject compliance or safety

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yeong-Shiau Pu, MD, PhD

Phone

886-2-23123456

Ext

65249

yspu@ntu.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Chung-Hsin Chen, MD

Phone

+886-922226230

duoncin.dan@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yeong-Shiau Pu, MD, PhD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yeong-Shiau Pu, MD, PhD

Phone

886-2-23123456

Ext

65249

yspu@ntu.edu.tw

First Name & Middle Initial & Last Name & Degree

Yeong-Shiau Pu, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

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