Prostate CancerG-MINORNCT02783950
Genomics in Michigan Impacting Observation or Radiation
A study testing Decipher Prostate Cancer Classifier in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 13 sites in United States.
Trial summary
To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone. 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?
- Decipher Prostate Cancer Classifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 13 sitesUnited States
- Study dates
- 17 Jan 2017to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Prostate cancer patients who have undergone radical prostatectomy
- PSA < 0.1 ng/ml at enrollment
- At least one of the following:
- pT3 (seminal vesicle invasion or extraprostatic extension), or
- Positive surgical margins
- Radical prostatectomy within one year of enrollment
Who cannot join
- Individuals who have any of the following will not be eligible to participate:
- Have regional or distant metastatic disease
- Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
- Node positive
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Urologic Consultants
Grand Rapids, Michigan, 49503
Urology Associates of Grand Rapids
Grand Rapids, Michigan, 49503
Michigan Urological Clinic
Grand Rapids, Michigan, 49546
Spectrum Health Medical Group- Urology
Grand Rapids, Michigan, 49546
Urology Surgeons, PC
Grand Rapids, Michigan, 49546
Comprehensive Medical Center, PLLC
Royal Oak, Michigan, 48073
Tri-City Urology
Saginaw, Michigan, 48601
Bay Area Urology Associates, PC
Traverse City, Michigan, 49684
Michigan Institute of Urology-Town Center
Troy, Michigan, 48084
IHA Urology at St. Joe's Ann Arbor
Ypsilanti, Michigan, 48197
About this study
Official title: Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.
Read the detailed description
This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.
The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.
- Conditions
- Prostate Cancer
- Being tested
- Decipher Prostate Cancer Classifier
- Keywords
- Genomics, Adjuvant Treatment
- 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 Prostate Cancer ClassifierOther
Also called Decipher Post-Op
The Decipher test (GenomeDx Biosciences, San Diego, CA) is a genomic test that predicts high grade disease, the probability of metastasis and prostate cancer-specific mortality for men with prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| GC (Decipher) Arm | Other | If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy. Receives: Other: Decipher Prostate Cancer Classifier |
| Usual-Care-Based (UC) Arm | No intervention | If enrolled during the UC period, only the CAPRA-S results will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)
Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.
Measured: within 18 months of radical prostatectomy
Secondary outcomes (5)
Time (From Randomization) to Adjuvant Treatment Administration
Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.
Measured: Up to 18 months post randomization
Time (From Randomization) to Salvage Treatment Administration
Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or >18 months after surgery in the absence of documented BCR
Measured: Up to 5 years post randomization
Time (From Randomization) to Biochemical Recurrence (BCR)
BCR is defined as PSA ≥ 0.2 ng/ml.
Measured: Up to 5 years post randomization
Time (From Randomization) to Metastatic Disease (Regional or Distant)
Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan
Measured: Up to 5 years post randomization
Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)
Composite Expanded Prostate Cancer Index Composite (EPIC)-26 domain scores for a) urinary irritative function, b) urinary incontinence, and c) sexual function will be measured at baseline and 24 months post-radical prostatectomy. Each of the 3 domains is scaled from 0-100 (higher is better).
Measured: Up to 24 months post radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start17 Jan 2017
- Primary completion1 Feb 2020
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Urological Surgery Improvement Collaborative (MUSIC), GenomeDx Biosciences Corp
- Responsible party
- Sponsor
- Investigators
- Todd Morgan, MD, Principal investigator, University of MichiganMichael Cher, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783950
- Sponsor's protocol ID
- UMCC 2016.020
- Other IDs
- CU 008, HUM00110858
- Acronym
- G-MINOR
- Status last verified
- Sep 2024
- First submitted
- 24 May 2016
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.
PubMed 15485730Badani 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 23592338Buja, A., Hastie, T. J. and Tibshirani, R. J. (1989). Linear smoothers and additive models (with discussion). Annals of Statistics, 17, 453-555.
Badani KK, Thompson DJ, Brown G, Holmes D, Kella N, Albala D, Singh A, Buerki C, Davicioni E, Hornberger J. Effect of a genomic classifier test on clinical practice decisions for patients with high-risk prostate cancer after surgery. BJU Int. 2015 Mar;115(3):419-29. doi: 10.1111/bju.12789. Epub 2014 Aug 11.
PubMed 24784420Campbell, Michael J., and Stephen J. Walters. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. John Wiley & Sons, 2014.
Erho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013.
PubMed 23826159Heo M, Leon AC. Comparison of statistical methods for analysis of clustered binary observations. Stat Med. 2005 Mar 30;24(6):911-23. doi: 10.1002/sim.1958.
PubMed 15558576Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB. Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11.
PubMed 23770138Den RB, Feng FY, Showalter TN, Mishra MV, Trabulsi EJ, Lallas CD, Gomella LG, Kelly WK, Birbe RC, McCue PA, Ghadessi M, Yousefi K, Davicioni E, Knudsen KE, Dicker AP. Genomic prostate cancer classifier predicts biochemical failure and metastases in patients after postoperative radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1038-1046. doi: 10.1016/j.ijrobp.2014.04.052. Epub 2014 Jul 8.
PubMed 25035207Cooperberg MR, Davicioni E, Crisan A, Jenkins RB, Ghadessi M, Karnes RJ. Combined value of validated clinical and genomic risk stratification tools for predicting prostate cancer mortality in a high-risk prostatectomy cohort. Eur Urol. 2015 Feb;67(2):326-33. doi: 10.1016/j.eururo.2014.05.039. Epub 2014 Jul 2.
PubMed 24998118Klein EA, Yousefi K, Haddad Z, Choeurng V, Buerki C, Stephenson AJ, Li J, Kattan MW, Magi-Galluzzi C, Davicioni E. A genomic classifier improves prediction of metastatic disease within 5 years after surgery in node-negative high-risk prostate cancer patients managed by radical prostatectomy without adjuvant therapy. Eur Urol. 2015 Apr;67(4):778-86. doi: 10.1016/j.eururo.2014.10.036. Epub 2014 Nov 12.
PubMed 25466945Den RB, Yousefi K, Trabulsi EJ, Abdollah F, Choeurng V, Feng FY, Dicker AP, Lallas CD, Gomella LG, Davicioni E, Karnes RJ. Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy. J Clin Oncol. 2015 Mar 10;33(8):944-51. doi: 10.1200/JCO.2014.59.0026. Epub 2015 Feb 9.
PubMed 25667284Ross AE, Johnson MH, Yousefi K, Davicioni E, Netto GJ, Marchionni L, Fedor HL, Glavaris S, Choeurng V, Buerki C, Erho N, Lam LL, Humphreys EB, Faraj S, Bezerra SM, Han M, Partin AW, Trock BJ, Schaeffer EM. Tissue-based Genomics Augments Post-prostatectomy Risk Stratification in a Natural History Cohort of Intermediate- and High-Risk Men. Eur Urol. 2016 Jan;69(1):157-65. doi: 10.1016/j.eururo.2015.05.042. Epub 2015 Jun 6.
PubMed 26058959Yamoah K, Johnson MH, Choeurng V, Faisal FA, Yousefi K, Haddad Z, Ross AE, Alshalafa M, Den R, Lal P, Feldman M, Dicker AP, Klein EA, Davicioni E, Rebbeck TR, Schaeffer EM. Novel Biomarker Signature That May Predict Aggressive Disease in African American Men With Prostate Cancer. J Clin Oncol. 2015 Sep 1;33(25):2789-96. doi: 10.1200/JCO.2014.59.8912. Epub 2015 Jul 20.
PubMed 26195723Lake S, Kammann E, Klar N, Betensky R. Sample size re-estimation in cluster randomization trials. Stat Med. 2002 May 30;21(10):1337-50. doi: 10.1002/sim.1121.
PubMed 12185888
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
- ClinicalTrials.gov ID
- NCT02783950
- Acronym / sponsor ID
- G-MINOR / UMCC 2016.020
- Conditions
- Prostate Cancer
- Keywords
- Genomics, Adjuvant Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Michigan Urological Surgery Improvement Collaborative (MUSIC), GenomeDx Biosciences Corp
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.
Detailed description
This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.
The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC (Decipher) Arm | Other | Other: Decipher Prostate Cancer ClassifierIf enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy. |
| Usual-Care-Based (UC) Arm | No intervention | –If enrolled during the UC period, only the CAPRA-S results will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate cancer patients who have undergone radical prostatectomy
- PSA < 0.1 ng/ml at enrollment
- At least one of the following:
- Radical prostatectomy within one year of enrollment
Key exclusion criteria (4 listed)
- Individuals who have any of the following will not be eligible to participate:
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 |
|---|---|---|
| Decipher Prostate Cancer ClassifierAlso: Decipher Post-OpThe Decipher test (GenomeDx Biosciences, San Diego, CA) is a genomic test that predicts high grade disease, the probability of metastasis and prostate cancer-specific mortality for men with prostate cancer. | Other | GC (Decipher) Arm |
Primary outcome
Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)
Time frame: within 18 months of radical prostatectomy
Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.
5 secondary outcomes
Time (From Randomization) to Adjuvant Treatment Administration
Time frame: Up to 18 months post randomization
Time (From Randomization) to Salvage Treatment Administration
Time frame: Up to 5 years post randomization
Time (From Randomization) to Biochemical Recurrence (BCR)
Time frame: Up to 5 years post randomization
Time (From Randomization) to Metastatic Disease (Regional or Distant)
Time frame: Up to 5 years post randomization
Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)
Time frame: Up to 24 months post radical prostatectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15485730Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.
- Background: PubMed 23592338Badani 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.
- BackgroundBuja, A., Hastie, T. J. and Tibshirani, R. J. (1989). Linear smoothers and additive models (with discussion). Annals of Statistics, 17, 453-555.
- Background: PubMed 24784420Badani KK, Thompson DJ, Brown G, Holmes D, Kella N, Albala D, Singh A, Buerki C, Davicioni E, Hornberger J. Effect of a genomic classifier test on clinical practice decisions for patients with high-risk prostate cancer after surgery. BJU Int. 2015 Mar;115(3):419-29. doi: 10.1111/bju.12789. Epub 2014 Aug 11.
- BackgroundCampbell, Michael J., and Stephen J. Walters. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. John Wiley & Sons, 2014.
- Background: PubMed 23826159Erho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013.
- Background: PubMed 15558576Heo M, Leon AC. Comparison of statistical methods for analysis of clustered binary observations. Stat Med. 2005 Mar 30;24(6):911-23. doi: 10.1002/sim.1958.
- Background: PubMed 23770138Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB. Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11.
- Background: PubMed 25035207Den RB, Feng FY, Showalter TN, Mishra MV, Trabulsi EJ, Lallas CD, Gomella LG, Kelly WK, Birbe RC, McCue PA, Ghadessi M, Yousefi K, Davicioni E, Knudsen KE, Dicker AP. Genomic prostate cancer classifier predicts biochemical failure and metastases in patients after postoperative radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1038-1046. doi: 10.1016/j.ijrobp.2014.04.052. Epub 2014 Jul 8.
- Background: PubMed 24998118Cooperberg MR, Davicioni E, Crisan A, Jenkins RB, Ghadessi M, Karnes RJ. Combined value of validated clinical and genomic risk stratification tools for predicting prostate cancer mortality in a high-risk prostatectomy cohort. Eur Urol. 2015 Feb;67(2):326-33. doi: 10.1016/j.eururo.2014.05.039. Epub 2014 Jul 2.
- Background: PubMed 25466945Klein EA, Yousefi K, Haddad Z, Choeurng V, Buerki C, Stephenson AJ, Li J, Kattan MW, Magi-Galluzzi C, Davicioni E. A genomic classifier improves prediction of metastatic disease within 5 years after surgery in node-negative high-risk prostate cancer patients managed by radical prostatectomy without adjuvant therapy. Eur Urol. 2015 Apr;67(4):778-86. doi: 10.1016/j.eururo.2014.10.036. Epub 2014 Nov 12.
- Background: PubMed 25667284Den RB, Yousefi K, Trabulsi EJ, Abdollah F, Choeurng V, Feng FY, Dicker AP, Lallas CD, Gomella LG, Davicioni E, Karnes RJ. Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy. J Clin Oncol. 2015 Mar 10;33(8):944-51. doi: 10.1200/JCO.2014.59.0026. Epub 2015 Feb 9.
- Website for MUSICLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Todd Morgan, MD principal investigator
University of Michigan
Michael Cher, MD principal investigator
Wayne State University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decipher Prostate Cancer Classifier in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 13 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 6 inclusion and 4 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) (time frame: within 18 months of radical prostatectomy). 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 NCT02783950, which also lists 23 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 26 Sep 2024.