AzTrials
AzTrials

Prostate CancerASSESS-DNCT02034825

Multi-site Decision Impact Study for Decipher

An observational study of Prostate Cancer, run by GenomeDx Biosciences Corp at 3 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Prostate Cancer
What is being tested?
Decipher Questionnaire
How many people
50 participants
Where
3 sitesUnited States
Study dates
Jan 2013to Jan 2015
Phase
Observational
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively

Who may be able to join

  • Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by AUA and NCCN guidelines:
  • Pathological T3 stage of disease (i.e., ECE or SVI)
  • Positive surgical margins, or
  • Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Who cannot join

  • Metastatic Disease (M+) prior to surgery
  • Failure of PSA to nadir after surgery
  • Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
  • Received any adjuvant chemotherapy
  • Required patient clinical data (Section 5.3) is not available for evaluation of eligibility criteria
  • Lack of documented treatment or management recommendation on file
  • Tissue specimen is inadequate for sampling and analysis

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Florida Hospital

    Celebration, Florida, 34747

  • Cedar Associates LLC

    Menlo Park, California, 94025

  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Official title: ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery

This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.

Read the detailed description

The clinical utility of Decipher will be evaluated at two time-points:

  1. Post RP - within 6 months after surgery
  2. PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations

Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome.

The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients.

Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ):

  1. Pre-Decipher: will collect information on their recommended treatment decision and their decision confidence based on the de-identified clinical and pathological information provided for each patient case.
  2. Post-Decipher: will collect their treatment recommendation and decision confidence for each de-identified patient case in the presence of the Decipher test results.
Conditions
Prostate Cancer
Being tested
Decipher Questionnaire
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Decipher QuestionnaireOther

    Each participant will complete the pre and post-Decipher eCRQs for a minimum of 5 cases, and a maximum of 25 cases.

Study groups in NCT02034825
Study groupRoleWhat they receive
Practicing urologic surgeons* US board-certified * Practicing urologic surgeons * Performing at least 40 radical prostate surgeries annually Urologists will be excluded from participating in the study if: * They are unable to identify a the required number of eligible patient cases with available clinical data and tissue specimens; * They have spent less than 3 years in practice or perform less than 40 RP's per year All participants will be asked to complete a questionnaire based on a random selection of retroactively selected cases.
Receives: Other: Decipher Questionnaire

What is being measured

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

  1. Change in treatment recommendation

    Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation. Specifically this will be defined as (pre- to post-):

    RT to ADT RT to ADT \& RT RT to Observation ADT to RT ADT to ADT \& RT ADT to Observation ADT \& RT to RT ADT \& RT to ADT ADT \& RT to Observation Observation to RT Observation to ADT Observation to RT \& ADT

    Measured: 1.5 years

Secondary outcomes (6)

  1. Specific change in treatment recommendation

    1. Change in treatment recommendation from pre- to post-Decipher report defined as any of the following: Observation to Any treatment Any treatment to Observation

    Measured: 1.5 years

  2. Changes in intensity of treatment

    1. Change in treatment recommendation from pre- to post-Decipher report involving an increase or decrease in intensity defined as:
    • Increasing intensity: RT to ADT RT to ADT \& RT ADT to ADT \& RT Observation to any treatment
    • Decreasing intensity: Any treatment to observation ADT \& RT to ADT ADT \& RT to RT ADT to RT

    Measured: 1.5 years

  3. Change in treatment recommendation compared to baseline

    Changes in treatment recommendation (as described in the Primary Endpoint, and in Secondary Endpoints 1 and 2) from original, actual, treatment recommendation and post-Decipher recommendation.

    Measured: 1.5 years

  4. Confidence in treatment recommendation

    Changes in urologists expressed level of confidence in the treatment recommendation

    Measured: 1.5 years

  5. Changes in the decision conflict scale

    Measured: 1.5 years

  6. Utility of Decipher

    Urologist's perception regarding the utility of the Decipher test

    Measured: 1.5 years

Timeline

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

  1. First posted14 Jan 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02034825
Sponsor's protocol ID
CU003
Acronym
ASSESS-D
Status last verified
Mar 2015
First submitted
10 Jan 2014
Last updated
29 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • Silberstein JL, Vickers AJ, Power NE, Fine SW, Scardino PT, Eastham JA, Laudone VP. Reverse stage shift at a tertiary care center: escalating risk in men undergoing radical prostatectomy. Cancer. 2011 Nov 1;117(21):4855-60. doi: 10.1002/cncr.26132. Epub 2011 Apr 11.

    PubMed 21484780

  • Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23.

    PubMed 19167731

  • Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.

    PubMed 16099293

  • Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Storkel S, Willich N, Semjonow A, Souchon R, Stockle M, Rube C, Weissbach L, Althaus P, Rebmann U, Kalble T, Feldmann HJ, Wirth M, Hinke A, Hinkelbein W, Miller K. Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol. 2009 Jun 20;27(18):2924-30. doi: 10.1200/JCO.2008.18.9563. Epub 2009 May 11.

    PubMed 19433689

  • Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.

    PubMed 17105795

  • Schreiber D, Rineer J, Sura S, Teper E, Nabhani T, Han P, Schwartz D, Choi K, Rotman M. Radical prostatectomy for cT3-4 disease: an evaluation of the pathological outcomes and patterns of care for adjuvant radiation in a national cohort. BJU Int. 2011 Aug;108(3):360-5. doi: 10.1111/j.1464-410X.2010.09875.x. Epub 2010 Nov 18.

    PubMed 21087395

  • Badani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918.

    PubMed 23592338

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by GenomeDx Biosciences Corp at 3 sites in United States.

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 4 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: finished, as of the sponsor's last update on 29 Feb 2016. 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 United States. 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.

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?

Change in treatment recommendation (time frame: 1.5 years). 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 NCT02034825, which also lists 7 linked publications.

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 29 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in