NCT01398657

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 14, 2012

Status Verified

March 1, 2012

Enrollment Period

2.9 years

First QC Date

July 14, 2011

Last Update Submit

November 13, 2012

Conditions

Prostate Cancer

Keywords

localizedHigh riskProstate CancerRandomizedCryotherapyCryoablationAdjuvantAndrogen Deprivation TherapyHormone therapyADT

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (6)

  • Time to the composite endpoint of treatment failure since cryoablation

    3 years

  • Biochemical (PSA) recurrence rate at 3 years

    3 years

  • Biochemical (PSA) recurrence-free survival

    3 years

  • Biopsy-proven recurrence rate at 3 years

    3 years

  • Biopsy-proven recurrence-free survival

    3 years

  • +1 more secondary outcomes

Study Arms (2)

Adjuvant Androgen-Deprivation Therapy

EXPERIMENTAL

Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy

Drug: Adjuvant Androgen-Deprivation Therapy

No adjuvant therapy

NO INTERVENTION

Cryotherapy without any adjuvant therapy

Interventions

Adjuvant Androgen-Deprivation TherapyDRUG

Short-term adjuvant androgen-deprivation therapy

Also known as: Adjuvant hormone therapy
Adjuvant Androgen-Deprivation Therapy

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Yeong-Shiau Pu, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeong-Shiau Pu, MD, PhD

CONTACT

886-2-23123456yspu@ntu.edu.tw

Chung-Hsin Chen, MD

CONTACT

+886-922226230duoncin.dan@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2016

Last Updated

November 14, 2012

Record last verified: 2012-03

Locations

TW(1)