Phase II Evaluation of EMD 121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen Independent Prostate Cancer

Inclusion Criteria:

- A histologic or cytologic diagnosis of prostate cancer

- No evidence of metastatic disease, or local progression

- PSA-only progression despite androgen deprivation therapy and antiandrogen withdrawal
(28 days for flutamide and 42 days for bicalutamide or nilutamide); PSA progression
is defined as 3 consecutive rising levels, with an interval of > 1 week between each
determination; the last determination must have a minimum value of >= 2 ng/ml and be
determined within two weeks prior to registration

- If the third confirmatory value is less than the previous value, the patient
will still be eligible if a repeat value (No. 4) is found to be greater than the
second value

- Patients must continue on LHRH agonists; they also may continue on any stable doses
(considered stable, if on current medicine dosing for one month or longer) of megace
or corticosteroids; they must be off all other therapies intended to treat the cancer
for 4 weeks

- ECOG performance status of 0-2

- No prior EMD 121974 therapy is allowed

- No investigational or commercial agents or therapies may be administered with the
intent to treat the patient's malignancy

- Testosterone < 50 ng/dl; patients must continue primary androgen deprivation with an
LHRH agonist, if they have not undergone orchiectomy

- Four weeks must have elapsed since major surgery

- Life expectancy of greater than 6 months

- Patients must have normal organ and marrow function as defined below obtained within
14 days prior to registration:

- ANC >= 1,500/µl

- Platelet count >= 100,000/ µl

- Creatinine =< 1.5 x upper limits of normal

- Bilirubin within normal limits

- SGOT (AST) =< 2.5 x upper limits of normal

- SGPT (ALT) =< 2.5 x upper limits of normal

- PSA >= 2 ng/ml

- The effects of EMD 121974 on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because antiangiogenic agents are
known to be teratogenic, men must agree to use adequate contraception prior to study
entry and for the duration of study participation

- Ability to understand and the willingness to sign a written informed consent that is
approved by the Institutional Human Investigation Committee

Exclusion Criteria:

- Patients may continue on a daily Multi-Vitamin, but all other herbal, alternative and
food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be
discontinued before registration

- Patients on stable doses of bisphosphonates which have been started no less than 6
weeks prior to protocol therapy, that show subsequent PSA progression, may continue
on this medication, however patients are not allowed to initiate bisphosphonate
therapy immediately prior or during the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Patients with a "currently active" second malignancy, other than non-melanoma skin
cancers or superficial bladder cancer, are not eligible; patients are not considered
to have a "currently active" malignancy if they have completed therapy and are now
considered without evidence of disease for 2 years