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

NCT ID: NCT01398657

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adjuvant Androgen-Deprivation Therapy

Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy

Group Type EXPERIMENTAL

Adjuvant Androgen-Deprivation Therapy

Intervention Type DRUG

Short-term adjuvant androgen-deprivation therapy

No adjuvant therapy

Cryotherapy without any adjuvant therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adjuvant Androgen-Deprivation Therapy

Short-term adjuvant androgen-deprivation therapy

Intervention Type DRUG

Other Intervention Names

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Adjuvant hormone therapy

Eligibility Criteria

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Inclusion Criteria

1. Age\>20 years
2. Histopathology proven prostate adenocarcinoma
3. Non-metastatic localized disease
4. Prostate cancer is deemed high-risk for recurrence(PSA\>20 ng/ml, Gleason score\>=8, or clinical staging\>=T2c)
5. Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
6. 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.
7. 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.
8. Subjects are willing to sign the informed consent and agree to comply with the study procedures

Exclusion Criteria

1. Those who have been treated with \> 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
2. 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
3. Other conditions the investigators think may affect subject compliance or safety
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeong-Shiau Pu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yeong-Shiau Pu, MD, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Chung-Hsin Chen, MD

Role: CONTACT

Phone: +886-922226230

Email: [email protected]

Facility Contacts

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Yeong-Shiau Pu, MD, PhD

Role: primary

Other Identifiers

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201103057MB

Identifier Type: -

Identifier Source: org_study_id