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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Adjuvant Androgen-Deprivation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant Androgen-Deprivation Therapy<br>Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy | Drug: Adjuvant Androgen-Deprivation Therapy<br>* Short-term adjuvant androgen-deprivation therapy<br>* Other names: Adjuvant hormone therapy;|
| No Intervention: No adjuvant therapy<br>Cryotherapy without any adjuvant therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the composite endpoint of treatment failure since cryoablation | Time to the composite endpoint of treatment failure since cryoablation | 3 years | 
| Biochemical (PSA) recurrence rate at 3 years | Biochemical (PSA) recurrence rate at 3 years | 3 years | 
| Biochemical (PSA) recurrence-free survival | Biochemical (PSA) recurrence-free survival | 3 years | 
| Biopsy-proven recurrence rate at 3 years | Biopsy-proven recurrence rate at 3 years | 3 years | 
| Biopsy-proven recurrence-free survival | Biopsy-proven recurrence-free survival | 3 years | 
| Safety profile | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized, High risk, Prostate Cancer, Randomized, Cryotherapy, Cryoablation, Adjuvant, Androgen Deprivation Therapy, Hormone therapy, ADT