Clinical trial NCT01398657: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
Official title: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: localized
High risk
Prostate Cancer
Randomized
Cryotherapy
Cryoablation
Adjuvant
Androgen Deprivation Therapy
Hormone therapy
ADT
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 182
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: A composite trifecta endpoint of treatment failure at 3 years after cryoablation
timeFrame: 3 years
Secondary outcomes:
measure: Time to the composite endpoint of treatment failure since cryoablation
timeFrame: 3 years
measure: Biochemical (PSA) recurrence rate at 3 years
timeFrame: 3 years
measure: Biochemical (PSA) recurrence-free survival
timeFrame: 3 years
measure: Biopsy-proven recurrence rate at 3 years
timeFrame: 3 years
measure: Biopsy-proven recurrence-free survival
timeFrame: 3 years
measure: Safety profile
timeFrame: 3 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yeong-Shiau Pu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: