Clinical trial · Interventional
Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced 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: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer. PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.
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 |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| Exemestane+bicalutamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive oral exemestane once daily
- interventionNames
- Drug: Exemestane
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive exemestane as in arm I and oral bicalutamide once daily
- interventionNames
- Drug: Exemestane+bicalutamide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage IV adenocarcinoma of the prostate
* Documented disease progression based on prostate-specific antigen (PSA) progression during first-line androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy)
* PSA progression is defined by the following:
* Interval of at least 1 week between reference value (time point value 1) and the next PSA level (time point value 2)
* PSA at time point value 3 is greater than PSA at time point value 2 OR
* PSA at time point value 3 is not greater than PSA at time point value 2, but PSA at time point value 4 is greater than PSA at time point value 2
* PSA at least 5 ng/mL
* Must continue primary androgen suppression if no prior surgical castration
* No known leptomeningeal or brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,500/mm\^3
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* No acute concurrent severe infection
* No other concurrent significant disease that would preclude study therapy
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior antibody or gene therapy
Chemotherapy:
* No prior cytostatic agents
Endocrine therapy:
* See Disease Characteristics
* No prior estramustine
* No prior antiandrogens (e.g., bicalutamide)
* No concurrent estrogen-containing medicine
Radiotherapy:
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy to more than 1 field
Surgery:
* See Disease Characteristics
Other:
* At least 4 weeks since prior investigational drugsReferences
Publications (0)
Data not yet available