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Trial record 2 of 1543 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT01398657
Recruitment Status : Unknown
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 20, 2011
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Adjuvant Androgen-Deprivation Therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to the composite endpoint of treatment failure since cryoablation [ Time Frame: 3 years ]
    Time to the composite endpoint of treatment failure since cryoablation

  2. Biochemical (PSA) recurrence rate at 3 years [ Time Frame: 3 years ]
    Biochemical (PSA) recurrence rate at 3 years

  3. Biochemical (PSA) recurrence-free survival [ Time Frame: 3 years ]
    Biochemical (PSA) recurrence-free survival

  4. Biopsy-proven recurrence rate at 3 years [ Time Frame: 3 years ]
    Biopsy-proven recurrence rate at 3 years

  5. Biopsy-proven recurrence-free survival [ Time Frame: 3 years ]
    Biopsy-proven recurrence-free survival

  6. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398657


Contacts
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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
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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
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Principal Investigator: Yeong-Shiau Pu, MD, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01398657     History of Changes
Other Study ID Numbers: 201103057MB
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: March 2012
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:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Hormones
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents