Clinical trial · Interventional
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study
NCT01398657CI-TRIAL-00008487unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Androgen-Deprivation Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant Androgen-Deprivation Therapy
- description
- Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy
- interventionNames
- Drug: Adjuvant Androgen-Deprivation Therapy
- type
- NO_INTERVENTION
- label
- No adjuvant therapy
- description
- Cryotherapy without any adjuvant therapy
Primary outcomes (1)
- measure
- A composite trifecta endpoint of treatment failure at 3 years after cryoablation
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.