Clinical trial · Interventional
Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer
Neoadjuvant Androgen Deprivation Therapy and Chemotherapy Followed by Radical Prostatectomy in Patients With Prostate Cancer
NCT02494713CI-TRIAL-00035940terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow enrollment; resource re-allocation
Summary
Brief summary (as posted)
This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Estramustine | Drug | Estramustine | ALIAS |
| Ketoconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ADT + chemotherapy
- description
- Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.
- interventionNames
- Drug: Degarelix
- Drug: Doxorubicin
- Drug: Ketoconazole
- Drug: Docetaxel
- Drug: Estramustine
Primary outcomes (1)
- measure
- Efficacy as Measured by Pathologic Response
- timeFrame
- Day of prostate removal, which is about 5 months following the day participant signed consent.
- description
- Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3. No neuroendocrine differentiation or small cell features. * Recent (\<6 weeks prior to study entry) negative bone scan and CT of the chest and abdomen. * Appropriate surgical candidate for radical prostatectomy and a performance status of \<2 (ECOG scale). * Adequate bone marrow function as defined as an absolute peripheral granulocyte count \>1500 and platelet count \>100,000. * Adequate hepatic function per the following criteria: * Albumin ≥2.8 g/dL * AST and ALT ≤5 x ULN * Total bilirubin \<2 mg/dL * Adequate renal function per the following criteria: o Serum creatinine ≤1.5 x ULN * Normal coagulation profile (INR ≤ 1.5, aPTT ≤ 1.5 x ULN for the lab) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency). * Age ≥ 18 years * Written informed consent to participate in this study. Exclusion Criteria: * Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features * Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first ADT and chemotherapy treatment * Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or investigational study drug. * Unable to tolerate multiparametric MRI or is contraindicated. * Patients not appropriate surgical candidates for radical prostatectomy based on the evaluation of coexistent medical diseases and competing causes of death. * Patients with uncontrolled cardiac, hepatic, renal, or neurologic/psychiatric disorder. * Severe gastrointestinal bleeding within 12 weeks of treatment with ADT and chemotherapy * Patients who are HIV positive or have chronic hepatitis B or C infections. * Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a 2D echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months of enrollment demonstrates a left ventricular ejection fraction \>45%. * Sensory neuropathy grade \>1. * History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer. * Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment. * Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.