Clinical trial · Interventional
Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca
Predicting Response to Platinum Chemotherapy in Metastatic Castration Resistant Prostate Ca(mCRPC)Using a Genomic Signature for "BRCAness": A Phase II Prospective Open Label Clinical Trial of Satraplatin in Men With mCRPC Who Have Progressed on Docetaxel
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to test genes for BRCAness(BRCA\[BReast CAncer\] gene) Studying these genes could help predict which patients would benefit from treatment with satraplatin, a medication being used for subjects who have failed prior chemotherapy. All subjects will have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene signature may be able to predict response to satraplatin and a tool will be developed to be able to screen patients likely to benefit from satraplatin. Subjects will all receive Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered responders if they have measurable disease meeting criteria for partial or complete response. PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Satraplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Satraplatin, Single Arm
- interventionNames
- Drug: Satraplatin
Primary outcomes (1)
- measure
- Efficacy of Satraplatin as Second Line Therapy in Men With CRCP
- timeFrame
- 3 months
- description
- Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.
Secondary outcomes (3)
- measure
- Number of Days to Maximum Decline in PSA
- timeFrame
- baseline and 3 months
- description
- Response rate - Maximum decline in PSA that occurs during treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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