Prostatic NeoplasmPhase 2PRO-PLATNCT02311764
Carboplatin in Castration-resistant Prostate Cancer
A Phase 2 study testing Carboplatin in people with Prostatic Neoplasm, run by Aurelius Omlin at 3 sites in Switzerland.
Trial summary
Open label, non-randomised phase II clinical pilot study Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Feb 2015to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- Progression of disease by any of the criteria listed here:
- PSA utilizing PCWG 2 criteria
- Bone scan
- RECIST 1.1
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Cantonal Hospital Chur
Chur, Kanton Graubünden, 7000
Luzern Cantonal Hospital
Lucerne
Cantonal Hospital St.Gallen
Sankt Gallen, 9007
About this study
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
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
- Conditions
- Prostatic Neoplasm
- Being tested
- Carboplatin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Carboplatin will be administered weekly
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin | Experimental | Carboplatin will be administered weekly Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Soft tissue or PSA Response
Measured: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
Secondary outcomes (7)
Rate of PSA declines of ≥30%
PSA
Measured: Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months)
OS
Overall survival (OS) form start of Carboplatin
Measured: Time Frame: livelong follow-up
rPFS
Radiological progression-free survival (rPFS) from start of carboplatin
Measured: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
PSA
Time to PSA progression
Measured: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety as per CTC AEv4.03
Number of patients with adverse events
Measured: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Disease control rate
Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria
Measured: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
PTEN loss
Evaluation of PTEN loss by FISH (Frequency and correlation with IHC)
Measured: Pre-study biopsy sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurelius Omlin
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharma, University Hospital, Zürich
- Responsible party
- Sponsor-investigator, Aurelius Omlin, Cantonal Hospital of St. Gallen
- Investigators
- Aurelius G Omlin, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311764
- Sponsor's protocol ID
- CTU-14005
- Acronym
- PRO-PLAT
- Status last verified
- Jan 2020
- First submitted
- 2 Dec 2014
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02311764
- Acronym / sponsor ID
- PRO-PLAT / CTU-14005
- Conditions
- Prostatic Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aurelius OmlinUniversity, hospital or other
- Collaborators
- Teva Pharma, University Hospital, Zürich
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, non-randomised phase II clinical pilot study
Detailed description
Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin | Experimental | Drug: CarboplatinCarboplatin will be administered weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinCarboplatin will be administered weekly | Drug | Carboplatin |
Primary outcome
Response
Time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
Soft tissue or PSA Response
7 secondary outcomes
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)
OS
Time frame: Time Frame: livelong follow-up
rPFS
Time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
PSA
Time frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety as per CTC AEv4.03
Time frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Disease control rate
Time frame: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
PTEN loss
Time frame: Pre-study biopsy sample
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelius G Omlin, MD principal investigator
Cantonal Hospital of St. Gallen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin in people with Prostatic Neoplasm, run by Aurelius Omlin at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.