Clinical trial · Interventional
Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer
An Open Label Randomized Phase 2 Study To Evaluate The Activity, Tolerability, And Toxicity Of Combined Neoadjuvant Anti-angiogenesis and Androgen Ablation Therapy in Men Undergoing 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): Sponsor withdrew drug.
Summary
Brief summary (as posted)
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| antiandrogen therapy | Procedure | — | UNRESOLVED |
| antiangiogenesis therapy | Procedure | — | UNRESOLVED |
| bicalutamide | Drug | Bicalutamide | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| releasing hormone agonist therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment
- measure
- Tumor response in terms of conventional histopathology as measured by prostatectomy specimens and Gleason scores in comparison to pre-treatment biopsies
- measure
- Tumor response in terms of molecular markers as measured by changes in VEGF, VEGF-flt-1, and integrin Alpha6Beta4, AlphaVBeta3, and AlphaVBeta5 expression in pre-treatment biopsy and post-treatment prostatectomy specimens
Secondary outcomes (3)
- measure
- Safety, feasibility, and tolerability as measured by CTCAE v3.0
- measure
- Prostate-specific antigen (PSA) serology as measured by PSA value during and after completion of study treatment
- measure
- Survival for up to 3 years after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Locally advanced disease
* No metastatic disease
* High-risk characteristics, meeting ≥ 1 of the following criteria:
* Large, hard tumor on digital exam
* Aggressive-appearing cancer cells on biopsy
* Prostate-specific antigen \> 10 ng/mL
PATIENT CHARACTERISTICS:
Performance status
* 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 11.0 g/dL
Hepatic
* Bilirubin \< 2 times upper limit of normal (ULN)
* SGOT and SGPT \< 2 times ULN
* PT and PTT normal
Renal
* Creatinine \< 1.8 g/dL
Cardiovascular
* No history of ventricular arrhythmia or dysfunction
* No congestive heart failure
* No symptomatic coronary artery disease
* No prior myocardial infarction
* No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the past 12 months
* No other significant cardiovascular disease
Pulmonary
* No pulmonary embolism within the past 12 months
* No exercise-limiting respiratory disease
Other
* Fertile patients must use effective barrier method contraception
* No sexual intercourse for 6 weeks after surgery
* No uncontrolled diabetes
* No serious acute infection
* No other malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior squalamine lactate
Chemotherapy
* No prior chemotherapy for prostate cancer
* No concurrent anticancer chemotherapy
Endocrine therapy
* No concurrent systemic corticosteroids
Radiotherapy
* No prior radiotherapy for prostate cancer
* No concurrent radiotherapy
Surgery
* No prior surgery for prostate cancer
* No other concurrent surgery
Other
* At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs that have estrogenic activity
* No participation in another investigational study within the past 3 months
* No concurrent participation in another investigational studyReferences
Publications (0)
Data not yet available