Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer
Brief summary
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.
Interventions
Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections. Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break
given as a 3 month depo-injection
given orally daily for 3 months
Sponsors
Study design
Eligibility
Inclusion criteria
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 agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate-specific Antigen (PSA) Response | 3 months after the start of treatment | — |
| Time to PSA Progression | From on study until time of PSA progression for up to two years | PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of \>= 1.0 ng/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 | From start of treatment until end of study, up to 6 months | — |
| Disease-free Interval | 3 months after combined treatment | This will only be analyzed if sample size warrants the analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A Only: Velcade Patients who were enrolled to Part A but did not move on to Part B. | 8 |
| Part B (Velcade + LH-RH Antagonist+Androgen Receptro Patients who were enrolled only to part B | 7 |
| Part A + Part B Patients who completed part A and moved in to part B. | 8 |
| Total | 23 |
Baseline characteristics
| Characteristic | Part A Only: Velcade | Part B (Velcade + LH-RH Antagonist+Androgen Receptro | Part A + Part B | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 4 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 6 Participants | 7 Participants | 20 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 8 participants | 23 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 8 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 7 / 7 | 8 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 7 | 0 / 8 |
Outcome results
Prostate-specific Antigen (PSA) Response
Time frame: 3 months after the start of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Velcade | Prostate-specific Antigen (PSA) Response | 1 participants |
| Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor) | Prostate-specific Antigen (PSA) Response | 6 participants |
| Part A + Part B | Prostate-specific Antigen (PSA) Response | 5 participants |
Time to PSA Progression
PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of \>= 1.0 ng/ml.
Time frame: From on study until time of PSA progression for up to two years
Population: Only patients with a CR were included in the analysis. No patients in Part A had a complete response. Time to progression for Part B only and Part A+Part B was calculated together. The information for the confidence interval is not available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor) | Time to PSA Progression | 5.49 months |
Disease-free Interval
This will only be analyzed if sample size warrants the analysis.
Time frame: 3 months after combined treatment
Population: data was not collected for this outcome measure.
Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0
Time frame: From start of treatment until end of study, up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Velcade | Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 | 8 participants |
| Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor) | Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 | 7 participants |
| Part A + Part B | Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 | 8 participants |