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Everolimus First-line Therapy in Non-rapidly Progressive Castration Resistant Prostate Cancer (CRPC). A Multicenter Phase II Trial.

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Everolimus First-line Therapy in Non-rapidly Progressive Castration Resistant Prostate Cancer (CRPC). A Multicenter Phase II Trial.



- Determine the progression-free survival at 12 weeks of patients with non-rapidly
progressive castration-resistant prostate cancer treated with everolimus as first-line

- Assess the activity and safety of this regimen in these patients.


- Determine the progression-free survival at 24 weeks of patients treated with this

- Determine the percentage of PSA response from baseline to 12 weeks in patients treated
with this regimen.

- Determine the changes in PSA-doubling time in patients treated with this regimen.

- Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up at 28 days and then every 3

Inclusion Criteria


- Histologically confirmed metastatic or locally advanced adenocarcinoma of the

- No curative therapy available

- Oligosymptomatic or asymptomatic patients

- Tumor progression after ≥ 1 hormonal treatment (orchiectomy or luteinizing-hormone
releasing-hormone [LHRH] agonist) with documented total testosterone levels ≤ 1.7
nmol/L (≤ 50 ng/dL)

- Concurrent LHRH agonist therapy is required for patients who have not been
surgically castrated

- Must have stopped antiandrogen therapy ≥ 6 weeks before the start of trial
treatment without withdrawal response

- PSA progression defined as an increase in PSA ≥ 25% (and an absolute increase of 2
ng/mL or more) over nadir value on hormonal therapy measured on 3 successive
occasions ≥ 1 week apart

- If the third measurement is not higher than the second, a fourth measurement
will be taken (patient allowed if the fourth measurement is higher than the

- PSA doubling time ≥ 55 days

- No known or suspected CNS metastases


- WHO performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 90 g/L

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 2.5 times ULN

- Creatinine clearance ≥ 40 mL/min

- Fasting serum cholesterol ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 times ULN

- Appropriate lipid-lowering medication allowed in case one or both of these
thresholds are exceeded

- Patient compliance and geographic proximity that would allow proper staging and
follow-up are required

- No malignancy within the past 5 years except curatively treated localized nonmelanoma
skin cancer or Ta and Tis bladder cancer

- No known history of HIV

- No serologically confirmed hepatitis B or C

- No serious underlying medical condition that, in the judgment of the investigator,
could impair the ability of the patient to participate in the trial including, but
not limited to, any of the following conditions:

- Uncontrolled or acute severe infection

- Uncontrolled diabetes

- Advanced chronic obstructive pulmonary disease

- No psychiatric disorder precluding understanding of information on trial-related
topics, giving informed consent, or interfering with compliance for oral drug intake

- No known hypersensitivity to trial drug or hypersensitivity to any of its components


- See Disease Characteristics

- No prior chemotherapy, radioisotopes, small molecules, immunotherapy, or
investigational drug therapy for prostate cancer

- No local radiotherapy within the past 2 weeks

- No major surgery within the past 4 weeks

- No concurrent radiotherapy

- No concurrent angiotensin converting enzyme inhibitors

- No concurrent chronic immunosuppressive therapy including high-dose corticosteroids
(i.e., > 25 mg prednisone equivalent per day)

- No products known to affect PSA levels (e.g., PC Calm, PC Plus, PC SPES, finasteride,
or fluconazole) within the past 4 weeks or concurrently

- No strong CYP3A4 inhibitors (e.g., itraconazole, erythromycin, clarithromycin,
diltiazem, verapamil, or grapefruit or its juice) within the past 2 weeks or

- No strong CYP3A4 inducers (e.g., phenytoin, rifampicin, carbamazepine, phenobarbital,
or St. John wort) within the past 2 weeks or concurrently

- No concurrent bisphosphonates

- Patients must continue to receive bisphosphonates regularly if it was started
prior to entering the trial

- No concurrent experimental drugs or other anticancer therapy in a clinical trial
within the past 30 days

- No concomitant drugs contraindicated for use with the trial drug according to the
investigator's drug brochure

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

at 12 weeks

Safety Issue:


Principal Investigator

Arnoud Templeton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kantonsspital St. Gallen


Switzerland: Swissmedic

Study ID:

SAKK 08/08



Start Date:

September 2009

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • hormone-resistant prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms