Trial Outcomes & Findings for Sandostatin for Patients With Androgen Independent Prostate Cancer (NCT NCT00510224)

NCT ID: NCT00510224

Last Updated: 2013-12-11

Results Overview

Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2013-12-11

Participant Flow

Men with prostate adenocarcinoma that had progressed despite androgen deprivation therapy were recruited for participation at one U.S. clinical site (UCSF)

Participant milestones

Measure	Octreotide Acetate Octreotide acetate 30mg intramuscular every 28 days
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sandostatin for Patients With Androgen Independent Prostate Cancer

Baseline characteristics by cohort

Measure	Octreotide Acetate n=13 Participants Octreotide acetate 30mg intramuscular every 28 days
Age Continuous	75 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Primary therapy Prostatectomy	3 participants n=5 Participants
Primary therapy Radiation Therapy	6 participants n=5 Participants
Primary therapy Androgen Deprivation	4 participants n=5 Participants
Median PSA	36.2 ng/ml n=5 Participants
Gleason Score	8 Score n=5 Participants
Hemoglobin	13.9 gm/dl n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: n=27 was determined to be sufficient to test for a 20% PSA response proportion compared with a null hypothesis of 5%. A two-stage design was employed to carry out an interim analysis for efficacy. As no patient showed a PSA decline among the first 13 accrued after 3 cycles (the first evaluation of PSA response), accrual was discontinued

Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.

Outcome measures

Measure	Octreotide Acetate n=13 Participants Octreotide acetate 30mg intramuscular every 28 days
PSA Response	0 Participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).

Outcome measures

Measure	Octreotide Acetate n=13 Participants Octreotide acetate 30mg intramuscular every 28 days
Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1. IGF-1	-34.5 percent change Interval -57.4 to 11.1
Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1. IGFBP-1	76.3 percent change Interval -45.1 to 589.6

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Octreotide Acetate n=13 Participants Octreotide acetate 30mg intramuscular every 28 days
Grade 4-5 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: 12 Weeks

Population: The trial was closed for futility after no PSA responses were observed among the first 13 patients, and this analysis was not performed

Outcome measures

Outcome data not reported

Adverse Events

Octreotide Acetate

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Octreotide Acetate n=13 participants at risk Octreotide acetate 30mg intramuscular every 28 days
Cardiac disorders Angina	7.7% 1/13 • While on study therapy (9-51 weeks)
Eye disorders Blurred vision	7.7% 1/13 • While on study therapy (9-51 weeks)
Gastrointestinal disorders Diarrhea	38.5% 5/13 • While on study therapy (9-51 weeks)
Nervous system disorders Dysgeusia	7.7% 1/13 • While on study therapy (9-51 weeks)
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13 • While on study therapy (9-51 weeks)
Blood and lymphatic system disorders Elevated INR	7.7% 1/13 • While on study therapy (9-51 weeks)
General disorders Fatigue	23.1% 3/13 • While on study therapy (9-51 weeks)
Gastrointestinal disorders Flatulence	23.1% 3/13 • While on study therapy (9-51 weeks)
General disorders Headache	7.7% 1/13 • While on study therapy (9-51 weeks)
Hepatobiliary disorders Hepatic congestion	7.7% 1/13 • While on study therapy (9-51 weeks)
Renal and urinary disorders Hyperkalemia	7.7% 1/13 • While on study therapy (9-51 weeks)
General disorders Pain	7.7% 1/13 • While on study therapy (9-51 weeks)
Eye disorders Scleral hemorrhage	7.7% 1/13 • While on study therapy (9-51 weeks)

Additional Information

Charles J. Ryan, MD

UCSF

Phone: 415-353-9279

Email: ryanc@medicine.ucsf.edu

Results disclosure agreements

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