Please assess the completion status of the following clinical trial:

Trial Title: Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~* Patients with CRPC with metastatic bone disease. At least one site of metastatic disease must be amenable to a needle biopsy. Bone sites include lumbar vertebrae, pelvic bones and long bones. Excluded sites are thoracic, cervical vertebrae, skull and rib lesions~* Patients may have had a number of previous hormonal therapies including ketoconazole and abiraterone, provided these were discontinued \>3 months before starting the trial~* Patients may have had any number of previous cytotoxic therapies~* Castrate resistant disease as defined by PSA working group. Patients must have a rise in PSA on two successive determinations at least one week apart and PSA levels 5ng/ml or greater and testosterone levels \<50~* Adequate renal, hepatic and bone marrow function as outlined in protocol~* PTT\< 60, INR \<1.5NL unless on warfarin therapy~* \> 6 month life expectancy~* At least a 4 week interval from previous treatment other than LHRH analog and bisphosphonates. Patients on bicalutamide must have discontinued this medication for at least 6 weeks to be eligible~* Patients receiving bisphosphonate can be maintained on this therapy~* No major surgery or radiation therapy within 4 weeks~* No strontium-89 or samarium-153 therapy within 4 weeks~* ECG showing normal QT interval~* No thromboembolism in past 6 months~* Age \> 18 years~* Investigator must check current patient medications against the list of CYP3A4 inhibitors and inducers prior to registration~* Echocardiogram or MUGA demonstrating ejection fraction within institutional normal limits~Exclusion Criteria:~* No previous therapy with lapatinib~* No previous therapy with ketoconazole within 3 months of starting trial~* The use of complementary therapy directed at prostate cancer treatment excluding the following: green tea, commercial multivitamin preparations. Vitamin B complex, C, D, E and multivitamins are permitted if these are being taken at less than 3 times the RDA~* The concomitant use of drugs known to be narrow therapeutic index CYP3A4 substrates are excluded~* Drugs that are sensitive to CYP3A4 substrates are excluded~* Patients taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes are excluded.~* Patients who have alcohol or drug dependence currently or in the last 6 months are excluded from this study~* Any other events, other than those defined above, in the opinion of the investigator, may make the patient ineligible for this trial~* No contraindication to biopsy such as bleeding disorders. Patients on anticoagulants such as warfarin must be able to safely stop the drug for a three-day period. Patients may not go on heparin during this time~* No active malignancy other than skin cancer or superficial bladder cancer~* Cardiac disease: congestive heart failure \> class II NYHA. Patients must no have unstable angina or new onset angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients must have an ejection fraction within normal limits at the enrolling institution based on an echocardiogram~* Uncontrolled hypertension defined as sustained BP \> 160 and diastolic \> 100 despite optimal medical management~* Known HIV or chronic Hep B or C~* Thrombolic or embolic events such as CVA within the last 6 months~* Pulmonary hemorrhage or any bleeding event CTCAE Grade 2 or greater within 6 months of first dose of study drug of KHAD~* Serious non-healing wound, ulcer, or bone fracture~* Evidence of history of bleeding diathesis or coagulopathy~* Major surgery or significant traumatic injury within 4 weeks of first study drug of KHAD

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Phase I Dose Level 1 (DL1): KHAD+L (250 mg) (Type: EXPERIMENTAL): For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day~Participants are treated until unacceptable toxicity, disease progression or withdrawal.
- Phase I Dose Level 2 (DL2): KHAD+L (500 mg) (Type: EXPERIMENTAL): For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
- All Phase I Participants (Type: EXPERIMENTAL): For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.~Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day~Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: according to the established dose escalation schedule~Participants are treated until unacceptable toxicity, disease progression or withdrawal.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: safety issues