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TerminatedNCT02311764PRO-PLATUpdated Jan 23, 2020

Carboplatin in Castration-resistant Prostate Cancer

A Phase 2 interventional study of Carboplatin in Prostatic Neoplasm, sponsored by Aurelius Omlin. Terminated at 3 sites in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Aurelius Omlin · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

Open label, non-randomised phase II clinical pilot study

Read the detailed description

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

02

Conditions studied

  • Prostatic Neoplasm

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 16 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Aurelius Omlin is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Carboplatin

    Carboplatin will be administered weekly

    Drug: Carboplatin

Interventions

  • DrugCarboplatin

    Carboplatin will be administered weekly

06

What researchers measure

Primary outcomes

  1. Response

    Soft tissue or PSA Response

    Time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months

Secondary outcomes

  1. Rate of PSA declines of ≥30%

    PSA

    Time frame: Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months)

  2. OS

    Overall survival (OS) form start of Carboplatin

    Time frame: Time Frame: livelong follow-up

  3. rPFS

    Radiological progression-free survival (rPFS) from start of carboplatin

    Time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months

  4. PSA

    Time to PSA progression

    Time frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months

  5. Safety as per CTC AEv4.03

    Number of patients with adverse events

    Time frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months

  6. Disease control rate

    Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria

    Time frame: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months

  7. PTEN loss

    Evaluation of PTEN loss by FISH (Frequency and correlation with IHC)

    Time frame: Pre-study biopsy sample

07

Study locations

3 sites
  • Cantonal Hospital Chur
    Chur, Graubuenden 7000, Switzerland
  • Luzern Cantonal Hospital
    Luzern, Switzerland
  • Cantonal Hospital St.Gallen
    St.Gallen, 9007, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02311764
Lead sponsor
Aurelius Omlin
Collaborators
Teva Pharma, University Hospital, Zürich
Responsible party
Aurelius Omlin (MD, Cantonal Hospital of St. Gallen) — Sponsor-investigator
First posted
Dec 8, 2014
Start date
Feb 2015
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Jan 23, 2020

Study contacts

Aurelius G Omlin, MD
principal investigator · Cantonal Hospital St. Gallen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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