Clinical trial · Interventional
The Role of Androgen Deprivation Treatment (ADT) in Docetaxe-Prednisolone Chemotherapy for Castrate-Resistant Prostatic Cancer
Randomized Phase II Screening Trial of Docetaxel Plus Prednisolone With or Without Androgen Deprivation Treatment in Castrate-Resistant Prostatic Cancer
NCT01487902CI-TRIAL-00005899unknownPhase 2ClinicalTrials.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)
The purpose of this study is to assess the androgen deprivation therapy when patients with castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.
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 |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT | Drug | — | UNRESOLVED |
| No ADT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ADT arm
- description
- Concomitant androgen deprivation treatment
- interventionNames
- Drug: ADT
- type
- ACTIVE_COMPARATOR
- label
- No ADT arm
- description
- No concomitant androgen deprivation treatment arm
- interventionNames
- Drug: No ADT
Primary outcomes (1)
- measure
- Time to PSA progression
- timeFrame
- 1 year
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Clinical or radiologic evidence of metastatic disease * Documented disease progression during hormone therapy (ADT with or without antiandrogen) * Cessation of ADT at least 4 weeks in non-orchiectomized patients * Adequate duration (at least 4 weeks for flutamide and 6 weeks for bicalutamide) of anti-androgen withdrawal (only for patients who showed a response or decline in PSA for more than 3 months) * KPS ≥ 60 * No prior cyto-toxic chemotherapy (except estramustine) or radioisotopes * No prior radiotherapy 25% or more of the bone marrow * No peripheral neuropathy grade 2 or worse * Adequate organ and bone marrow function Exclusion Criteria: * Other tumor type than adenocarcinoma * Presence or history of CNS metastasis * Other serious illness or medical conditions
References
Publications (0)
Data not yet available
No reference posted for this study.