Clinical trial · Interventional
Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Loss of funding
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel (Single Arm)
- description
- Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
- interventionNames
- Drug: docetaxel
- Drug: prednisone
- Procedure: Radical prostatectomy
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
- timeFrame
- 5 years
- description
- Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate cancer * Prostate-specific antigen (PSA) level \> 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago * No lymph node-positive prostate cancer * No documented metastatic disease * CT scan of the abdomen and pelvis negative (within the past 6 months) * No bone pain OR negative bone scan (within the past 6 months) * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin normal * ALT and AST ≤ 1.5 times upper limit of normal * Alkaline phosphatase normal * Fertile patients must use effective contraception * No peripheral neuropathy \> grade 1 * No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer * No serious illness with a life expectancy of \< 5 years * No concurrent medical, psychological, or social circumstance that would preclude study compliance * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 Exclusion Criteria: * No prior orchiectomy * No prior chemotherapy regimen for this disease * No prior pelvic radiotherapy * No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride * Preoperative androgen manipulation for a duration of ≤ 3 months allowed * No prior immunotherapy * No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * No concurrent herbal or alternative regimens including, but not limited to, any of the following: * Saw palmetto * PC-SPES * Shark cartilage * No other concurrent investigational agents * No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
References
Publications (0)
Data not yet available