Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT01289067
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically confirmed adenocarcinoma of the prostate.
2. Radiographic evidence of metastatic disease (Bone scan, CT(Computerized Tomography) scan, or MRI(Magnetic Resonance Imaging) are acceptable) amenable to image-guided biopsy.
3. Castrate levels of testosterone (testosterone \<50 ng/dL) on androgen deprivation therapy (ADT). LHRH(luteinizing hormone releasing hormone)agonist therapy must continue while on study unless patient has previously undergone an orchiectomy.
4. The patient must have discontinued antiandrogens (bicalutamide, flutamide or nilutamide) 30 days prior to baseline PSA.
5. Progression on at least one line of a prior docetaxel-based chemotherapy.
6. Patients must have adequate organ and marrow function as defined below:
* Absolute neutrophil count \>1,500/μl
* Platelets \>100,000/μl
* GFR(glomerular Filtration Rate) \>30 ml/min
* ALT(Alanine transaminase) and AST(Aspartate transaminase) ≤ 2.5 X upper limit of normal (ULN) or ≤ 5 X ULN in patients with liver metastasis
7. Age \> 18 years
8. Ability to take oral medications (pills must be swallowed whole)
9. ECOG (Eastern Cooperative Oncology Group) performance status 0-2
10. Ability to understand and the willingness to sign a written informed consent document
11. Patients must be willing to undergo an image-guided biopsy of a metastatic site on at least one occasion.
12. Patient agrees to utilize contraception while enrolled in the trial
Exclusion Criteria:
1. Patients who have received prior treatment with a platinum chemotherapy.
2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), history of symptomatic congestive heart failure (NYHC (New York Heart Association Classification) III), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT(Super ventricular tachycardia)or any VT(ventricular tachycardia), or psychiatric illness/social situations that would limit compliance with study requirements.
3. Patients with a medical contraindication to image-guided biopsies
4. Patients with a severe allergic reaction to satraplatin compounds.
5. Has a history of a prior malignancy with the exception of the following: adequately treated basal cell or squamous cell skin cancer, or other cancers for which the subject has been disease-free for at least 5 years.
6. Has had radiation therapy within 30 days prior to being registered for protocol therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01289067
Study Brief:
Protocol Section:
NCT01289067