Clinical trial · Interventional
Docetaxel + Prednisone With or Without Radiation for Castrate Resistant Prostate Cancer
A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer
NCT01087580CI-TRIAL-00026265withdrawnPhase 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 main purpose of this study is to find out whether adding radiation therapy to the standard treatment of chemotherapy for prostate cancer is tolerated well and is more effective than the standard treatment of chemotherapy alone
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel and Prednisone | Drug | — | UNRESOLVED |
| Radiation Therapy | Drug | Radiation Therapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy alone, no radiation therapy
- description
- A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel
- interventionNames
- Drug: Docetaxel and Prednisone
- type
- EXPERIMENTAL
- label
- Chemotherapy with Radiation Therapy
- description
- A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week. GROUPS 2 Bone metastasis (bone scan index \< 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions. GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.
- interventionNames
- Drug: Docetaxel and Prednisone
- Drug: Radiation Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have a diagnosis of castrate resistant prostate cancer. * Participants must be 18 years old or older. * Biopsy of tissue from the prostate or enlarged lymph nodes may be required. * Patients must sign study specific informed consent prior to study entry. * Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards. Exclusion Criteria: * Participants cannot have prior chemotherapy for prostate cancer. * Participants cannot have prior radiation therapy to the pelvis.
References
Publications (0)
Data not yet available
No reference posted for this study.