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Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer

VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00103376
Enrollment
23
Registered
2005-02-08
Start date
2004-10-31
Completion date
2011-06-30
Last updated
2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

DRUGVelcade

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

DRUGLH-RH Agonist

given as a 3 month depo-injection

given orally daily for 3 months

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Prostate-specific Antigen (PSA) Response3 months after the start of treatment
Time to PSA ProgressionFrom on study until time of PSA progression for up to two yearsPSA 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

MeasureTime frameDescription
Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0From start of treatment until end of study, up to 6 months
Disease-free Interval3 months after combined treatmentThis will only be analyzed if sample size warrants the analysis.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total23

Baseline characteristics

CharacteristicPart A Only: VelcadePart B (Velcade + LH-RH Antagonist+Androgen ReceptroPart A + Part BTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants4 Participants4 Participants15 Participants
Age, Categorical
Between 18 and 65 years
1 Participants3 Participants4 Participants8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants6 Participants7 Participants20 Participants
Region of Enrollment
United States
8 participants7 participants8 participants23 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
8 Participants7 Participants8 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
8 / 87 / 78 / 8
serious
Total, serious adverse events
1 / 80 / 70 / 8

Outcome results

Primary

Prostate-specific Antigen (PSA) Response

Time frame: 3 months after the start of treatment

ArmMeasureValue (NUMBER)
Part A: VelcadeProstate-specific Antigen (PSA) Response1 participants
Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor)Prostate-specific Antigen (PSA) Response6 participants
Part A + Part BProstate-specific Antigen (PSA) Response5 participants
Primary

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.

ArmMeasureValue (MEDIAN)
Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor)Time to PSA Progression5.49 months
Secondary

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.

Secondary

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

ArmMeasureValue (NUMBER)
Part A: VelcadeNumber of Patients Who Experienced an Adverse Event by CTCAE v. 2.08 participants
Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor)Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.07 participants
Part A + Part BNumber of Patients Who Experienced an Adverse Event by CTCAE v. 2.08 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026