Trial Outcomes & Findings for A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer (NCT NCT01084759)

NCT ID: NCT01084759

Last Updated: 2016-05-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2016-05-09

Participant Flow

Participant milestones

Measure	Testosterone Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Etoposide and Testosterone n=16 Participants Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Prostate Specific Antigen (PSA)	20 ng/mL n=5 Participants
Testosterone	20 ng/dL n=5 Participants
Baseline Gleason Grade (higher grade indicates more pathologic atypia) Gleason score 6	4 participants n=5 Participants
Baseline Gleason Grade (higher grade indicates more pathologic atypia) Gleason score 7	7 participants n=5 Participants
Baseline Gleason Grade (higher grade indicates more pathologic atypia) Gleason score 8	3 participants n=5 Participants
Baseline Gleason Grade (higher grade indicates more pathologic atypia) Gleason score 9	2 participants n=5 Participants
Length of continuous androgen deprivation therapy	45.5 months n=5 Participants
Number of second line hormonal therapies received None	2 participants n=5 Participants
Number of second line hormonal therapies received 1 second line agent	9 participants n=5 Participants
Number of second line hormonal therapies received 2 second line agents	3 participants n=5 Participants
Number of second line hormonal therapies received 3 second line agents	2 participants n=5 Participants
Bone metastases Patients with bone metastases	3 participants n=5 Participants
Bone metastases Patients without bone metastases	13 participants n=5 Participants
RECIST evaluable soft tissue metastases Patients with RECIST evaluable disease	10 participants n=5 Participants
RECIST evaluable soft tissue metastases Patients without RECIST evaluable disease	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	Treatment Group n=14 Participants Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.	42.9 Percentage of Participants Interval 20.6 to 68.8

PRIMARY outcome

Timeframe: 2 years

Time to a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart.

Outcome measures

Measure	Treatment Group n=14 Participants Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
Time to PSA Progression	221 days Interval 95.0 to 454.0

SECONDARY outcome

Timeframe: 2 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Treatment Group n=14 Participants Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)	7 participants

Adverse Events

Treatment Group

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=16 participants at risk Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	12.5% 2/16 • 3 years
Infections and infestations Neutropenic fever	6.2% 1/16 • 3 years

Other adverse events

Measure	Treatment Group n=16 participants at risk Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
Gastrointestinal disorders Nausea	62.5% 10/16 • 3 years
Nervous system disorders Fatigue	56.2% 9/16 • 3 years
Skin and subcutaneous tissue disorders Alopecia	56.2% 9/16 • 3 years
Blood and lymphatic system disorders Edema	50.0% 8/16 • 3 years
Blood and lymphatic system disorders Anemia	12.5% 2/16 • 3 years
Reproductive system and breast disorders Priapism	6.2% 1/16 • 3 years

Additional Information

Dr. Samuel Denmeade

SKCCC at Johns Hopkins

Phone: 410-955-8875

Email: denmesa@jhmi.edu

Results disclosure agreements

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