Trial Outcomes & Findings for Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle (NCT NCT00586898)

NCT ID: NCT00586898

Last Updated: 2016-03-25

Results Overview

Complete Response: Normalization of the PSA (\< or = to 4.0 for patients with castrate metastatic disease, or \< 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by \> or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-03-25

Participant Flow

Participant milestones

Measure	All Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Overall Study STARTED	36
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	All Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Overall Study Adverse Event	1
Overall Study Patiemt Non-compliance	1
Overall Study Evaluable for Toxicity Only	5

Baseline Characteristics

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Baseline characteristics by cohort

Measure	All Participants n=36 Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.

Outcome measures

Measure	All Participants n=29 Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Response Complete Response (CR)	22 participants
Response Partial Response (PR)	4 participants
Response Stable Disease (SD)	3 participants

Adverse Events

All Participants

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=36 participants at risk Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.8% 1/36 • Number of events 1
Cardiac disorders Cardiovascular, other	2.8% 1/36 • Number of events 1

Other adverse events

Measure	All Participants n=36 participants at risk Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 6/36 • Number of events 6
General disorders Hot Flashes	19.4% 7/36 • Number of events 7
Metabolism and nutrition disorders Hyperglycemia	22.2% 8/36 • Number of events 8
Metabolism and nutrition disorders Hyperkalemia	13.9% 5/36 • Number of events 5
Metabolism and nutrition disorders Hypoglycemia	5.6% 2/36 • Number of events 2
Metabolism and nutrition disorders SGPT (ALT)	8.3% 3/36 • Number of events 3

Additional Information

Dr. Howard Scher

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4323

Email: Scherh@mskcc.org

Results disclosure agreements

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