Clinical trial · Interventional
Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer
VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
NCT00103376CI-TRIAL-00035623terminatedPhase 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): Low Accrual
Summary
Brief summary (as posted)
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Receptor Antagonists | Drug | — | UNRESOLVED |
| LH-RH Agonist | Drug | — | UNRESOLVED |
| Velcade | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Velcade
- description
- Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break.
- interventionNames
- Drug: Velcade
- type
- EXPERIMENTAL
- label
- Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist
- description
- Patient will start Part B after completing Part A or may be enrolled to part B only.
- interventionNames
- Drug: Velcade
- Drug: LH-RH Agonist
- Drug: Androgen Receptor Antagonists
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Relapsed disease after definitive local therapy, as documented only by a rise in prostate-specific antigen (PSA)
* Experienced PSA relapse after definitive local therapy
* Rising PSA (≥ 1.0 ng/mL after nadir \< 1.0 ng/mL)
* PSA increase of ≥ 0.3 ng/mL (increase occurred between 2 separate measurements taken ≥ 4 weeks apart)
* The first of these two PSA values must rise above a previously recorded post-therapy nadir value
* Ineligible for curative therapy
* No clinical evidence of local recurrence (i.e., palpable induration or mass in the prostatic fossa) other than PSA elevation
* No evidence of palpable disease in the prostatic bed
* No metastatic disease (M0)
* No non-nodal (\> N1) metastasis
* No evidence of osseous metastasis on bone scan within the past 28 days
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-1
Life expectancy
* At least 1 year
Hematopoietic
* Platelet count ≥ 30,000/mm\^3
* Absolute neutrophil count ≥ 1,000/mm\^3
Hepatic
* No known hepatitis B or C positivity
Renal
* Creatinine clearance ≥ 30 mL/min
Immunologic
* No known human T-cell lymphotropic virus positivity
* No hypersensitivity to bortezomib, boron, or mannitol
* No known HIV 1 or 2 positivity
* No active, ongoing bacterial, viral, or fungal infection
Other
* Fertile patients must use effective contraception
* No peripheral neuropathy ≥ grade 2
* No other disease, condition, or social or geographic constraint that would preclude study participation
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 6 months since prior hormonal therapy combined with radiation therapy as definitive therapy
* Neoadjuvant hormonal therapy prior to definitive therapy (e.g., surgery, radiation therapy, brachytherapy, or cryoablation) allowed
* No other concurrent hormonal therapy
Radiotherapy
* See Disease Characteristics
* More than 12 months since prior radioactive seed therapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* More than 4 weeks since prior surgery
* No concurrent surgery
Other
* No concurrent second-line herbal preparations, including PC-SPES
* No other concurrent investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.