Carboplatin in Castration-resistant Prostate Cancer (PRO-PLAT)
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ClinicalTrials.gov Identifier: NCT02311764 |
Recruitment Status :
Terminated
First Posted : December 8, 2014
Last Update Posted : January 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasm | Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Single Arm Open Label Phase II Pilot Study of Carboplatin in Patients With Metastatic Castrationresistant Prostate Cancer (CRPC) and PTEN Loss and/or DNA Repair Defects |
Actual Study Start Date : | February 2015 |
Actual Primary Completion Date : | December 2019 |
Actual Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Carboplatin
Carboplatin will be administered weekly
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Drug: Carboplatin
Carboplatin will be administered weekly |
- Response [ Time Frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months ]Soft tissue or PSA Response
- Rate of PSA declines of ≥30% [ Time Frame: Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months) ]PSA
- OS [ Time Frame: Time Frame: livelong follow-up ]Overall survival (OS) form start of Carboplatin
- rPFS [ Time Frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months ]Radiological progression-free survival (rPFS) from start of carboplatin
- PSA [ Time Frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months ]Time to PSA progression
- Safety as per CTC AEv4.03 [ Time Frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months ]Number of patients with adverse events
- Disease control rate [ Time Frame: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months ]Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria
- PTEN loss [ Time Frame: Pre-study biopsy sample ]Evaluation of PTEN loss by FISH (Frequency and correlation with IHC)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written Informed Consent
- Adult patients with histological diagnosis of adenocarcinoma of the prostate.
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
- DNA repair defects as per central assessment
- Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
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Progression of disease by any of the criteria listed here:
- PSA utilizing PCWG 2 criteria
- Bone scan
- RECIST 1.1
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Adequate organ and bone marrow function as evidenced by:
- Haemoglobin ≥8.0 g/dL
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- AST and/or ALT < 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT <5 x ULN
- Total bilirubin < 2.0 x ULN (except for patients with Gilbert's disease)
- Creatinine Clearance ≥30ml/min
- Patient must agree in the biomarker studies including the fresh tumour biopsies
Exclusion Criteria:
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
- Prior treatment with any prior platinum based chemotherapy,
- Major surgery within 4 weeks prior to planned start of treatment
- Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Active secondary malignancy that requires systemic therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311764
Switzerland | |
Cantonal Hospital Chur | |
Chur, Graubuenden, Switzerland, 7000 | |
Luzern Cantonal Hospital | |
Luzern, Switzerland | |
Cantonal Hospital St.Gallen | |
St.Gallen, Switzerland, 9007 |
Principal Investigator: | Aurelius G Omlin, MD | Cantonal Hospital St. Gallen |
Responsible Party: | Aurelius Omlin, MD, Cantonal Hospital of St. Gallen |
ClinicalTrials.gov Identifier: | NCT02311764 |
Other Study ID Numbers: |
CTU-14005 |
First Posted: | December 8, 2014 Key Record Dates |
Last Update Posted: | January 23, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Prostatic Diseases Carboplatin Antineoplastic Agents |