Clinical trial · Interventional
Cryoablation Therapy or Radiotherapy Therapy for Stage III Prostate Cancer
A Prospective Multi-center Study to Compare the QOL and Efficacy of External Beam Radiation Therapy or Cryoablation Therapy for Stage III Prostate Cancer
NCT02605226CI-TRIAL-00028085CRYO-PCA-IIIunknownN/AClinicalTrials.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 trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with radiotherapy or cryoablation.
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 |
|---|---|---|---|
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| Cryoablation therapy | Procedure | — | UNRESOLVED |
| External beam radiation therapy | Radiation | — | UNRESOLVED |
| luteinizing-hormone releasing-hormone (LHRH) agonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. Patients receive cryoablation therapy.
- interventionNames
- Procedure: Cryoablation therapy
- Drug: bicalutamide
- Drug: luteinizing-hormone releasing-hormone (LHRH) agonist
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.
- interventionNames
- Radiation: External beam radiation therapy
- Drug: bicalutamide
- Drug: luteinizing-hormone releasing-hormone (LHRH) agonist
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate adenocarcinoma, T3aN0M0, T3bN0M0 * Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer * Survival ≥ 12 months * WHO performance status 0-2 * white blood cell ≥ 3.5 ×10\*9/L * Platelets ≥ 5×10\*9/L * Hemoglobin ≥ 10 g/dL Exclusion Criteria: * History of malignant disease * History of coronary artery disease * Uncontrolled infection * Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration) * Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
References
Publications (0)
Data not yet available
No reference posted for this study.