An observational study in Prostate Cancer, sponsored by Myriad Genetic Laboratories, Inc.. Terminated at 12 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by Myriad Genetic Laboratories, Inc. · Observational
Among 3,595 studies in Prostatic Neoplasms with a site in United States — 607 open to participants now, 977 under way, 101 of them phase 3. Prostatic Neoplasms · United States.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 66th largest by enrollment of the 477 observational ones that give a count, is one of 125 that started in 2015, is one of 482 observational ones, and was the 1,873rd registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →607 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+ · Men only
University of Michigan Rogel Cancer Center · Sites in United States
Ages 50–75 · Men only · Healthy volunteers
Clinton Bahler · Sites in United States
Ages 18+ · Men only
University of Miami · Sites in United States
Ages 18+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,595 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 898 · Phase 2 1,383 · Phase 3 321 · Phase 4 50
First in 1988; this study’s year is marked. 125 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,511 is above the median of 200 across 1,309 observational studies indexed under Prostatic Neoplasms.
Median enrollment 48 across the 3,023 interventional studies, 157 across the 477 observational. Of the 2,355 that completed or were terminated, 997 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
921 of 3,595 have an industry lead sponsor. The 10 most frequent:
Myriad Genetic Laboratories, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Myriad Genetic Laboratories, Inc. has 8 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
338 of the studies in Prostatic Neoplasms with a site in United States that are under way reach primary completion within a year, 25 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03348670Phase 3Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06970847Phase 3Clarity Pharmaceuticals Ltd64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer | 2026-12-31 |
| NCT02446405Phase 3University of SydneyEnzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | 2026-12-31 |
| NCT07427043Phase 3Brigham and Women's HospitalRobotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) | 2026-12-31 |
Add all 338 to your calendar (.ics) → With an account.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer.
This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered.
PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.
Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
Behavioral: Prolaris
Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result
Also known as: RNA expression signature based on a set of cell cycle progression (CCP) genes
Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment
Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris
Time frame: 6 months
Prolaris prediction of biochemical or objective recurrence
Biochemical recurrence (defined as PSA \>0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy
Time frame: 5 years
Prolaris prediction of who benefits from the addition of hormone therapy to contemporary radiation therapy
either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radiation who did or did not receive adjuvant ADT
Time frame: 5 years
Comparison of prognostic utility of prospective Prolaris testing of prostate biopsy samples to other clinical pathological parameters with respect to disease progression
either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radical prostatectomy or radiation
Time frame: 5 years
Association of Prolaris score with progression to active intervention when initially managed with AS or WW
Progression to interventional therapy in men initially managed with AS or WW
Time frame: 5 years
Prognostic utility of Prolaris testing compared to other clinical pathological parameters with respect to disease progression in men who were Gleason score <7 on initial biopsy
biochemical or objective recurrence of disease in men who were Gleason score \<7
Time frame: 5 years
Impact of Prolaris on magnitude of change between pre-Prolaris treatment selection and the post-Prolaris treatment plan following consultation with the patient
comparison of percentage change from the pre-Prolaris treatment option versus the post-Prolaris treatment plan
Time frame: 3 months
Impact of Prolaris on magnitude of change between physician likelihood of recommending non-interventional therapy and the likelihood following the genomic test results
mean change in the physician's likelihood of recommending watchful waiting or active surveillance post-genomic testing compared to pre-genomic testing
Time frame: 3 months
Plan to share: Yes — Results of Prolaris testing to be shared with provider and patient per commercial process; study results to be presented in a pier reviewed publication in aggregate form only (no individual participant data to be shared through publications or abstracts)
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in Mar 2022, 78 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Myriad Genetic Laboratories, Inc.