Clinical trial · Interventional
SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer
- 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)
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining SU5416, hormone therapy, and radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| flutamide | Drug | Flutamide | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| SU5416 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SU5416 in combination with hormone and radiation therapy
- description
- Subjects receive 5 months of hormone suppression therapy consisting of 1 month of Bicalutamide or Flutamide followed by 4 months of leuprolide or goserlin injections. After completion of at least 12 weeks of hormone therapy, subjects will receive 7 1/2 weeks of radiation therapy. SU5416 will be given by IV infusion starting 4 weeks before beginning radiation treatment and continuing until 4 weeks after completion of radiation. Multiple doses of SU5416 will be studied.
- interventionNames
- Drug: bicalutamide
- Drug: flutamide
- Drug: goserelin acetate
- Drug: leuprolide acetate
- Drug: SU5416
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Side effects of SU5416 in combination with standard hormone treatment and radiation in men with prostate cancer
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate with at least 1 of the following: Clinical stage T2b or greater Gleason score at least 8 Pretreatment PSA greater than 15 ng/mL Pelvic and/or periaortic node(s) positive on abdominal/pelvic CT scan Metastatic disease requiring palliation for local symptoms No known brain metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No symptomatic congestive heart failure No cardiac arrhythmia No uncompensated coronary artery disease on ECG or physical exam No myocardial infarction or severe unstable angina within the past 6 months No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: No other concurrent uncontrolled illness No ongoing or active infection No diabetes mellitus with severe peripheral vascular disease No psychiatric illness or social condition that would preclude study No prior allergic reactions attributed to compounds of similar chemical or biological composition to SU5416 or Cremophor EL vehicle No prior severe allergic reactions to paclitaxel or docetaxel PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent anticancer chemotherapy Endocrine therapy: Prior hormonal therapy of any duration allowed Radiotherapy: No prior pelvic radiotherapy Surgery: No prior prostatectomy Other: No prior non-hormonal systemic therapy for prostate cancer No other concurrent investigational or commercial agents or therapies for malignancy No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (0)
Data not yet available