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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01398657
First received: July 14, 2011
Last updated: November 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Adjuvant Androgen-Deprivation Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer — Open-Label Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • A composite trifecta endpoint of treatment failure at 3 years after cryoablation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Time to the composite endpoint of treatment failure since cryoablation

  • Biochemical (PSA) recurrence rate at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Biochemical (PSA) recurrence rate at 3 years

  • Biochemical (PSA) recurrence-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Biochemical (PSA) recurrence-free survival

  • Biopsy-proven recurrence rate at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Biopsy-proven recurrence rate at 3 years

  • Biopsy-proven recurrence-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Biopsy-proven recurrence-free survival

  • Safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Hormone therapy related toxicities such as liver function alteration, libido changes, alterations in quality of life as measured by QLQ C30 and PR25 questionnaire.


Estimated Enrollment: 182
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adjuvant Androgen-Deprivation Therapy
Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy
Drug: Adjuvant Androgen-Deprivation Therapy
Short-term adjuvant androgen-deprivation therapy
Other Name: Adjuvant hormone therapy
No Intervention: No adjuvant therapy
Cryotherapy without any adjuvant therapy

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398657

Contacts
Contact: Yeong-Shiau Pu, MD, PhD 886-2-23123456 ext 65249 yspu@ntu.edu.tw
Contact: Chung-Hsin Chen, MD +886-922226230 duoncin.dan@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yeong-Shiau Pu, MD, PhD    886-2-23123456 ext 65249    yspu@ntu.edu.tw   
Principal Investigator: Yeong-Shiau Pu, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yeong-Shiau Pu, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01398657     History of Changes
Other Study ID Numbers: 201103057MB
Study First Received: July 14, 2011
Last Updated: November 13, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
localized
High risk
Prostate Cancer
Randomized
Cryotherapy
Cryoablation
Adjuvant
Androgen Deprivation Therapy
Hormone therapy
ADT

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014