Know Cancer

forgot password

A Multicenter, Single-Arm, Open-Label, Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®) In Subjects With Androgen Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Multicenter, Single-Arm, Open-Label, Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®) In Subjects With Androgen Independent Prostate Cancer

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age > or = to 18 years at the time of signing the informed consent form.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Must have a histologic diagnosis of adenocarcinoma of the prostate.

5. Must be surgically or medically castrated. If the method is medical castration, the
subject must have a serum testosterone level of <50 ng/dl. The subject should
maintain treatment with LH RH antagonists or agonists.

6. Must have prostate cancer unresponsive or refractory to androgen blockade as
demonstrated by rising PSA.

-Rising PSA is defined as at least 2 consecutive rises in PSA to be documented over
the reference value (measure 1). The first rising PSA (measure 2) must be taken at
least 7 days after the reference value.

A third confirmatory PSA is required, and it must be obtained at least seven days
after the second measure. If this is not greater than measure 2, a fourth PSA is
required and this must be greater than measure 2.

-Absolute value of PSA > or = to 5 ng/ml on the last confirmatory assessment.

7. Prior treatment with antiandrogens such as flutamide, or other hormonal agents such
as estrogens, corticosteroids, or ketoconazole must have been stopped for at least 28
days prior to treatment.

In the case of nilandron and bicalutamide, treatment with these agents must have
stopped at least 42 days prior to treatment. Following completion of the
antiandrogen withdrawal period, either:

- One post withdrawal PSA value must be higher than the last pre-withdrawal PSA
value, or

- If the subject s PSA value decreased following the antiandrogen withdrawal
period then two increases in PSA values must be documented after the
post-withdrawal nadir.

8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
(Appendix II: ECOG Performance Status Scale).

Exclusion Criteria:

1. Metastatic prostate cancer

2. Any of the following laboratory abnormalities:

1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)

2. Platelet count <100,000 cells/mm3 (100 x 109/L)

3. Serum creatinine >2.5 mg/dL (221 mmol/L)

4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)

5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

3. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he were to participate in the study or confounds the
ability to interpret data from the study.

4. Prior history of malignancies other than AIPC (except for basal cell or squamous cell
carcinoma of the skin) unless the subject has been free of the disease for > or = to
1 year.

5. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

6. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.

7. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking

8. Prior use of lenalidomide.

9. Prior use of chemotherapy for androgen independent prostate cancer.

10. Use of any standard/experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy except LHRH agonists/antagonists.

11. Known active Hepatitis C.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the activity of lenalidomide monotherapy in subjects with androgen independent prostate cancer (AIPC).


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

April 2007

Related Keywords:

  • Prostate Cancer
  • Androgen Independent Prostate Cancer
  • Prostatic Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Seattle Cancer Care Alliance Seattle, Washington  98109
Dana Farber Cancer Institute Boston, Massachusetts  02115
Alta Bates Cancer Center Berkeley, California  94704
Moffit Cancer Center Tampa, Florida  33612