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Prostate CancerPhase 2NCT02928432

SWITCH: Study of the Prednisone to Dexamethasone Change in mCRPC Patients Treated With Abiraterone

A Phase 2 study testing Steroids switch in people with Prostate Cancer, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Abiraterone acetate (AA) has shown a favourable impact in overall survival, administered with prednisone to decrease the adverse event related to CYP171A suppression. Our hypothesis is that the change of prednisone to dexamethasone in CRPC patients that progress biochemically to AA + prednisone can improve the number… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Steroids switch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSpain
Study dates
Jun 2013to Jan 2017
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

  • Provision of signed informed consent
  • Patients must be 18 years old or older
  • Patients must have an acceptable performance status at study entry ECOG <2, without prior deterioration due to disease clinical progression on abiraterone plus prednisone
  • Patients must have prior histological confirmation of prostate cancer diagnosis prior to study entry
  • Maintained castration status to LHRH analogs/antagonist or surgical castration with Testosterone blood levels <0.5ng/mL should have been documented before the initiation of prior abiraterone plus prednisone treatment and confirmed again at study entry. Patients on LHRHa must be able to continue on them through the duration of the study.
  • Biochemical progression to abiraterone plus prednisone is required before study entry. This progression will be documented by a rising PSA value with an increase ≥25% and >2ng/dL over nadir, and must be confirmed by a second determination at least 2 weeks later should be documented before study entry.
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  • Candidates must be able to swallow pills and to continue with abiraterone acetate dose of 1000mg/24h and must not have any contraindication for dexamethasone use at 0.5 mg/24h.
  • Patients must be asymptomatic or do not have any symptomatic deterioration attributable to prostate cancer progression at study entry
  • Absence of significant radiological progression to abiraterone plus prednisone at study entry. Only those cases with limited progression will be eligible if: a) they have not developed any new visceral, nodal or other soft tissue metastases; b) their measurable target lesions on abiraterone plus prednisone according to RECIST 1.1 should have not increased more than 40% from baseline or from their best response on treatment measurements; and c) they must have < 3 new bone metastasis on bone-scan from baseline according to PCWG2
  • Acceptable hematological, hepatic and renal functions, without contraindications for the administration of abiraterone: a) WBC count >2000/mm^3; b) Haemoglobin level >10 g/dL; c) Platelets >75000/mm^3; AST/ALT <2.5 times the upper normal limit; Total bilirubin <1.5 times the upper normal limit; Creatinine value <1.5 times the upper normal limit or creatinine clearance >50 ml/min

Who cannot join

  • Any medical contraindication to continue on abiraterone acetate or to receive continuous daily low-dose of dexamethasone (0.5 mg/24h)
  • Any event which is considered clinical progression to abiraterone acetate by the attending physicians in the investigators team.
  • Any skeletal symptomatic event related to prostate cancer progression on abiraterone-acetate, except the administration of external beam radiotherapy due to bone-metastasis related-pain in a single area and which have resulted in a adequate symptom control for at least 4-weeks before study entry.
  • Radiological progression: a) New nodal, visceral or other soft tissue metastasis during the treatment with Abiraterone acetate and prednisone; b) increase of any target lesion >40% according to RECIST v1.1 criteria; c) any known visceral, nodal or soft tissue metastasis localisation causing symptomatic progression, and d) ≥ 3 new bone metastasis on bone-scan during treatment with abiraterone plus prednisone.
  • Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free, as well as subjects with a history of skin cancers (of non-melanoma type) or excised in situ carcinomas.
  • Any prior medical history, be they psychiatric or of any other character, which, according to the judgement of the investigator, might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish National Cancer Research Centre (CNIO)

    Madrid, Madrid, 28029

Other trials in Spain

About this study

Official title: Phase II Pilot Study of the Prednisone to Dexamethasone Switch in Metastatic Castration Resistant Prostate Cancer (CRPC) Patients With Asymptomatic Biochemical and/or Limited Radiological Progression on Abiraterone and Prednisone

Abiraterone acetate (AA) has shown a favourable impact in overall survival, administered with prednisone to decrease the adverse event related to CYP171A suppression.

Our hypothesis is that the change of prednisone to dexamethasone in CRPC patients that progress biochemically to AA + prednisone can improve the number and the length of the responses, and also improve tolerance to treatment, decreasing the adverse events associated to a moderate dosage of steroids used chronically.

Read the detailed description

This phase II multicentric-study analyse the role of the steroid switch in patients receiving AA. Previous retrospective data (Lorente et al, BJC 2014) has shown that the change of prednisone by dexamethasone in CRPC patients treated with AA post-docetaxel leaded to durable biochemical responses in 40% of cases. Recently, superiority of dexamethasone over prednisone in PSA response has been reported by a phase II trial that included 82 chemotherapy-naive metastatic CRPC patients.

In our study patients with biochemical and/or limited radiological progression to AA + prednisone are prospectively enrolled. The principal objective was to evaluate the percentage of PSA responses in clinically stable metastatic CRPC patients after at least 12 weeks of AA + prednisone. Secondary aims will include time to biochemical progression, time to first radiological progression, overall survival and the evaluation of the safety profile.

Biochemical response was monitored with PSA determinations every 4 weeks, and defined as a ≥ 30% decline in PSA from baseline, confirmed with a second reading. PSA progression was evaluated according to PCWG2 criteria. Radiological response was re-evaluated every 12-16 weeks using bone and CT-scan according to RECIST v1.1 and PCWG2 criteria.

Translational studies: archival tissue will be obtained from all patients, to perform PTEN and TMPRSS-ERG rearrangements evaluation. Plasma will be collected after AA + prednisone progression to study the androgen receptor status in plasma.

Conditions
Prostate Cancer
Being tested
Steroids switch
Keywords
Castration-Resistant Prostate Cancer, Abiraterone acetate, Steroids Switch
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Steroids switchDrug

    Change of prednisone 5mg/12h to dexamethasone 0.5mg/24h

Study groups in NCT02928432
Study groupRoleWhat they receive
Steroids switchExperimentalCRPC patients with biochemical and/or limited radiological progression after at least 12 weeks of AA + prednisone.
Receives: Drug: Steroids switch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the percentage of PSA response in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression.

    Biochemical response will be defined as a ≥ 30% decline in PSA from starting AA + dexamethasone, confirmed with a second PSA reading at least 2 weeks apart.

    Measured: 12 months

Secondary outcomes (6)

  1. To study time to biochemical (PSA) progression (>25% increase over PSA nadir value)in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression.

    Time to biochemical progression is defined as the time from AA + dexamethasone starting data, to PSA progression according to PCWG2 criteria

    Measured: 12 months

  2. To analyze the time to radiological progression in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression.

    Time to radiological progression is defined as the time from AA+ dexamethasone starting date to the first occurrence of either progression by bone scan or progression by CT-scan (based on RECIST v1.1 and PCWG2 criteria), or death resulting from any cause.

    Measured: 24 months

  3. To evaluate the overall survival in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression.

    Overall survival is defined as the time from AA + dexamethasone starting date to the death or last follow up visit.

    Measured: 24 months

  4. To report the safety profile in in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression.

    Toxicity events will be collected prospectively in each visit according to CTCAE v4.0 criteria.

    Measured: 24 months

  5. To describe the activity of subsequent treatment-line after AA + dexamethasone in the study population.

    Subsequent therapies and their corresponding biochemical/radiological responses will be also recorded.

    Measured: 24 months

  6. To explore potential androgen receptor pathway related circulating- and tissue-biomarkers in in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression.

    Archival tissue for immunohistochemistry and FISH, and peripheral blood to extract plasma and perform AR amplification studies by ddPCR analysis and determination of AR Alternative splicing transcripts from exosomes.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2016 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2016
  4. Study completionJan 2017

Resources

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
Model description
One-arm prospective
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02928432
Sponsor's protocol ID
CNIO-CP-05-2015
Status last verified
Jan 2017
First submitted
7 Oct 2016
Last updated
27 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Steroids switch in people with Prostate Cancer, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 1 site in Spain.

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 10 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the percentage of PSA response in metastatic CRPC treated with AA + dexamethasone with biochemical and/or limited radiological progression. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02928432.

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 27 Jan 2017.

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