Trial Outcomes & Findings for Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer (NCT NCT00103376)

NCT ID: NCT00103376

Last Updated: 2018-11-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 3 months after the start of treatment
• Results posted on: 2018-11-05

Participant Flow

Participant milestones

Measure	Part A Only: Velcade Patients who were enrolled to Part A but did not move on to Part B	Part B (Velcade+LH-RH Antagonist+Adrogen Receptor) Patients who were enrolled only to part B.	Part A + Part B Patients who completed part A and moved in to Part B.
Overall Study STARTED	8	7	8
Overall Study COMPLETED	8	7	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Part A Only: Velcade n=8 Participants Patients who were enrolled to Part A but did not move on to Part B.	Part B (Velcade + LH-RH Antagonist+Androgen Receptro n=7 Participants Patients who were enrolled only to part B	Part A + Part B n=8 Participants Patients who completed part A and moved in to part B.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	23 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 months after the start of treatment

Outcome measures

Measure	Part A: Velcade n=8 Participants Patients who were enrolled to Part A but did not move on to Part B	Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor) n=7 Participants Patients who were enrolled only to part B.	Part A + Part B n=8 Participants Patients who completed part A and moved in to Part B.
Prostate-specific Antigen (PSA) Response	1 participants	6 participants	5 participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Part A: Velcade Patients who were enrolled to Part A but did not move on to Part B	Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor) n=11 Participants Patients who were enrolled only to part B.	Part A + Part B Patients who completed part A and moved in to Part B.
Time to PSA Progression	—	5.49 months Interval 3.91 to NA is included to represent the value "infinity"	—

SECONDARY outcome

Timeframe: From start of treatment until end of study, up to 6 months

Outcome measures

Measure	Part A: Velcade n=8 Participants Patients who were enrolled to Part A but did not move on to Part B	Part B: (Velcade+LH-RH Antagonist+Adrogen Receptor) n=7 Participants Patients who were enrolled only to part B.	Part A + Part B n=8 Participants Patients who completed part A and moved in to Part B.
Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0	8 participants	7 participants	8 participants

SECONDARY outcome

Timeframe: 3 months after combined treatment

Population: data was not collected for this outcome measure.

This will only be analyzed if sample size warrants the analysis.

Outcome measures

Outcome data not reported

Adverse Events

Part A: Velcade Only

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Part B (Velcade+LH-RH Antagonist+Adrogen Receptor)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A + Part B

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Velcade Only n=8 participants at risk Patients who were enrolled to Part A but did not move on to Part B	Part B (Velcade+LH-RH Antagonist+Adrogen Receptor) n=7 participants at risk Patients who were enrolled only to part B.	Part A + Part B n=8 participants at risk Patients who completed part A and moved in to Part B.
Musculoskeletal and connective tissue disorders back pain	12.5% 1/8 • Number of events 1 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	0.00% 0/8 • from start of treatment until end of study visit, about 6 months

Other adverse events

Measure	Part A: Velcade Only n=8 participants at risk Patients who were enrolled to Part A but did not move on to Part B	Part B (Velcade+LH-RH Antagonist+Adrogen Receptor) n=7 participants at risk Patients who were enrolled only to part B.	Part A + Part B n=8 participants at risk Patients who completed part A and moved in to Part B.
Nervous system disorders neuropathy	100.0% 8/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	100.0% 8/8 • from start of treatment until end of study visit, about 6 months
General disorders fatigue	100.0% 8/8 • from start of treatment until end of study visit, about 6 months	71.4% 5/7 • from start of treatment until end of study visit, about 6 months	75.0% 6/8 • from start of treatment until end of study visit, about 6 months
Blood and lymphatic system disorders anemia	62.5% 5/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	87.5% 7/8 • from start of treatment until end of study visit, about 6 months
Blood and lymphatic system disorders thrombocytopenia	87.5% 7/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	100.0% 8/8 • from start of treatment until end of study visit, about 6 months
Blood and lymphatic system disorders neutropenia	75.0% 6/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	62.5% 5/8 • from start of treatment until end of study visit, about 6 months
Gastrointestinal disorders constipation	75.0% 6/8 • from start of treatment until end of study visit, about 6 months	57.1% 4/7 • from start of treatment until end of study visit, about 6 months	100.0% 8/8 • from start of treatment until end of study visit, about 6 months
Gastrointestinal disorders ileus	25.0% 2/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	0.00% 0/8 • from start of treatment until end of study visit, about 6 months
General disorders anorexia	25.0% 2/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	50.0% 4/8 • from start of treatment until end of study visit, about 6 months
Respiratory, thoracic and mediastinal disorders dyspnea	12.5% 1/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	0.00% 0/8 • from start of treatment until end of study visit, about 6 months
Musculoskeletal and connective tissue disorders weakness	25.0% 2/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	12.5% 1/8 • from start of treatment until end of study visit, about 6 months
Infections and infestations infection	12.5% 1/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	12.5% 1/8 • from start of treatment until end of study visit, about 6 months
Gastrointestinal disorders vomiting	25.0% 2/8 • from start of treatment until end of study visit, about 6 months	42.9% 3/7 • from start of treatment until end of study visit, about 6 months	25.0% 2/8 • from start of treatment until end of study visit, about 6 months
Infections and infestations shingles	12.5% 1/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	12.5% 1/8 • from start of treatment until end of study visit, about 6 months
General disorders pain	100.0% 8/8 • from start of treatment until end of study visit, about 6 months	57.1% 4/7 • from start of treatment until end of study visit, about 6 months	100.0% 8/8 • from start of treatment until end of study visit, about 6 months
Vascular disorders hypotension	12.5% 1/8 • from start of treatment until end of study visit, about 6 months	14.3% 1/7 • from start of treatment until end of study visit, about 6 months	25.0% 2/8 • from start of treatment until end of study visit, about 6 months
General disorders dizziness	37.5% 3/8 • from start of treatment until end of study visit, about 6 months	14.3% 1/7 • from start of treatment until end of study visit, about 6 months	12.5% 1/8 • from start of treatment until end of study visit, about 6 months
Psychiatric disorders insomnia	37.5% 3/8 • from start of treatment until end of study visit, about 6 months	0.00% 0/7 • from start of treatment until end of study visit, about 6 months	0.00% 0/8 • from start of treatment until end of study visit, about 6 months

Additional Information

Kate Anderton

Medical University of South Carolina

Phone: 843-792-2708

Email: anderton@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place