Carboplatin in Castration-resistant Prostate Cancer

Prostatic Neoplasm Clinical Trial

— PRO-PLAT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02311764
• Other study ID #: CTU-14005
• Status: Terminated
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label, non-randomised phase II clinical pilot study

Description:

Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written Informed Consent

2. Adult patients with histological diagnosis of adenocarcinoma of the prostate.

3. Metastatic Castration-Resistant Prostate Cancer (mCRPC)

4. 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).

5. DNA repair defects as per central assessment

6. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2

7. Progression of disease by any of the criteria listed here:

• PSA utilizing PCWG 2 criteria

• Bone scan

• RECIST 1.1

8. 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

9. Patient must agree in the biomarker studies including the fresh tumour biopsies

Exclusion Criteria:

1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin

2. Prior treatment with any prior platinum based chemotherapy,

3. Major surgery within 4 weeks prior to planned start of treatment

4. Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids

5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

6. Previous enrolment into the current study

7. Active secondary malignancy that requires systemic therapy.

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• Carboplatin
Carboplatin will be administered weekly

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Chur	Chur	Graubuenden
Switzerland	Luzern Cantonal Hospital	Luzern
Switzerland	Cantonal Hospital St.Gallen	St.Gallen

Sponsors (3)

Lead Sponsor	Collaborator
Aurelius Omlin	Teva Pharma, University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

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