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

November 13, 2012 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yeong-Shiau Pu, MD, PhD
  • Phone Number: 65249 886-2-23123456
  • Email: yspu@ntu.edu.tw

Study Contact Backup

Study Locations

      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yeong-Shiau Pu, MD, PhD
          • Phone Number: 65249 886-2-23123456
          • Email: yspu@ntu.edu.tw
        • Principal Investigator:
          • Yeong-Shiau Pu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant Androgen-Deprivation Therapy
Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy
Short-term adjuvant androgen-deprivation therapy
Other Names:
  • Adjuvant hormone therapy
No Intervention: No adjuvant therapy
Cryotherapy without any adjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite trifecta endpoint of treatment failure at 3 years after cryoablation
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the composite endpoint of treatment failure since cryoablation
Time Frame: 3 years
Time to the composite endpoint of treatment failure since cryoablation
3 years
Biochemical (PSA) recurrence rate at 3 years
Time Frame: 3 years
Biochemical (PSA) recurrence rate at 3 years
3 years
Biochemical (PSA) recurrence-free survival
Time Frame: 3 years
Biochemical (PSA) recurrence-free survival
3 years
Biopsy-proven recurrence rate at 3 years
Time Frame: 3 years
Biopsy-proven recurrence rate at 3 years
3 years
Biopsy-proven recurrence-free survival
Time Frame: 3 years
Biopsy-proven recurrence-free survival
3 years
Safety profile
Time Frame: 3 years
Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Adjuvant Androgen-Deprivation Therapy

3
Subscribe