Trial Outcomes & Findings for A Safety and Feasibility Study of Mitotane in Prostate Cancer (NCT NCT02057237)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

maintain 50% of the patients on Mitotane at the 12 week mark

Results posted on

2015-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm - Mitotane Mitotane will be administered on an outpatient or inpatient basis. Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Feasibility Study of Mitotane in Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm - Mitotane n=1 Participants Mitotane will be administered on an outpatient or inpatient basis. Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment Canada	1 participants n=93 Participants

PRIMARY outcome

Timeframe: maintain 50% of the patients on Mitotane at the 12 week mark

Population: As only 1 patient was accrued to this trial, no data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.

Continue increase of serum PSA beyond 8 weeks indicate PSA progression. Response and progression will be primarily evaluated in this study using PSA response criteria from the Prostate Cancer Working Group 2. Criteria used to define response include: at least a 50% decline in PSA, confirmed by a second measurement ≥4 weeks later. PSA progression is defined by a \>25% increase from baseline in patients whose PSA did not decrease, and of 50% from the nadir value in patients whose PSA decreased. This increase in PSA must be \>5 ng/ml, and confirmed by a second measurement, at least 1 week later; PSA nadir is defined as the minimum PSA value that was confirmed by a second measurement. PSA progression free survival is defined as the time between the randomization date and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm - Mitotane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Joshua

Princess Margaret Cancer Centre

Phone: 416-946-4501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place