Clinical trial · Interventional
Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding withdrawal
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel+IMRT | Drug | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I Dose 1-4
- description
- Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy (IMRT)
- Drug: Docetaxel+IMRT
- type
- EXPERIMENTAL
- label
- Phase II MTD Dose
- description
- Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
- interventionNames
- Drug: Docetaxel+IMRT
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
INCLUSION CRITERIA; DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Localized disease, meeting 1 of the following staging criteria:
* Clinical stage T2b (palpable bilateral movement) disease
* Surgically resectable T3 disease
* Meets any of the following high-risk\* features:
* PSA ≥ 15 ng/mL
* Gleason grade ≥ 4+3 (4+3, 4+4, or 5+any, but not 3+4) NOTE: \*High risk defined as \> 50% chance of failure with local therapy
* Plans to undergo prostatectomy as primary therapy
* No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan
* Scan only required in patients with a PSA ≥ 40 ng/mL
* No evidence of bone metastases by bone scan
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 10 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* White blood cell (WBC) \> 3,000/mm\^3
* Neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Direct bilirubin normal
* Alanine aminotransferase (ALT) \< 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase \[AP\] \> 2.5 times ULN)
* Alkaline phosphatase (AP) \< 4.0 times ULN
* No other serious medical condition that would preclude study treatment
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No peripheral neuropathy ≥ grade 2
* No hypersensitivity to drugs formulated with polysorbate 80
* No significant contraindications to corticosteroids
* No history of scleroderma
* No active inflammatory bowel disease (IBD) or IBD that is being medically treated
* Inclusion of patients with a remote history of IBD is at the discretion of radiotherapist
EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior therapy for prostate cancer, including any of the following:
* Conventional hormonal therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone therapy, antiandrogen therapy, or estrogen therapy)
* External-beam radiotherapy or brachytherapy
* Cryotherapy
* Cytotoxic chemotherapy
* No prior pelvic radiotherapyReferences
Publications (1)
- DERIVEDOhaegbulam KC, Post CM, Farris PE, Garzotto M, Beer TM, Hung A, Williamson CW. Safety and Efficacy of Neoadjuvant Docetaxel and Radiotherapy in Localized High-Risk Prostate Cancer: Results From a Prospective Pilot Study. Am J Clin Oncol. 2025 Feb 1;48(2):75-82. doi: 10.1097/COC.0000000000001151. Epub 2024 Oct 30. PMID 39473059