/A

Phase 1

• Conditions: Advanced hormone - and chemotherapy - resistant prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002087-24-GR
• Lead Sponsor: Hellenic Oncology Research Group (HORG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-20
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologically or cytologically confirmed prostate cancer in relapse
2. laboratory confirmation of hormone resistance by measuring LH, FSH, DHEA, testosterone.
3. continued increase of PSA despite adequate androgen blockade and administration of at least one line of chemotherapy (docetaxel, vinorelbine).
4. ECOG Performance Status 0-2 (see Appendix I)
5. Patients must be >18 and =80 years
6. life expectancy >=3 months
7. signed informed consent
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
9. Patients with both measurable and non measurable disease will be allowed to enter the trial and will be followed for response as described in Section 6.1.1 of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1. concomitant use of any other antineoplastic treatment with the exception of LHRH inhibitors and bisphosphonates for the treatment of bone metastases
2. chronic active hepatitis or cirrhosis or billirubin>1.5 the upper limit of normal (ULN)
3. active infection, cachexia or serious psychiatric disease
4. isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy
5. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
6. Diagnosis of any second malignancy, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
7. Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
8. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
10. Concurrent treatment with other experimental drugs and/or anticancer agents
11. Patients must be surgically sterile, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
12. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial
13. any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the efficacy objective response rate (ORR) of temsirolimus in patients with advanced hormone- and chemotherapy-resistant prostate cancer;Secondary Objective: • To evaluate the median Time To Progression (TTP) and overall survival (OS) of temsirolimus in patients with advanced hormone- and chemotherapy-resistant prostate cancer. <br>• To evaluate the safety and tolerability of temsirolimus in this patient population<br>;Primary end point(s): • Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: After the treatment completion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Overall Survival (OS) <br>• Time to Progression (TTP)<br>• Safety<br><br>For the translational research:<br>• Evaluation of angiogenic factors, measurement of circulating tumor cells, and enumeration of immunosuppressive cells (Tregs, MDSCs, Thy17).;Timepoint(s) of evaluation of this end point: At the end of the study