Prostatic NeoplasmPROGRESSNCT05129605
Prostate Cancer Genetic Risk Evaluation and Screening Study
An observational study of Prostatic Neoplasm and Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. Read more about this study
- Who is it for?
- Ages 35 to 74 years, men only
- Conditions the study is for
- Prostatic Neoplasm, Prostate Cancer, BRCA2 Mutation
- What is being tested?
- Prostate cancer screening
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to Dec 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men ages 35-74 years old at high genetic risk for prostate cancer on the basis of a specific germline genetic mutation or a strong family history.
Who may be able to join
- Men 35-74 years old
- No known diagnosis of prostate cancer
- Life expectancy >10 years
- Meet cohort A, B, or C criteria
- Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
- Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
- Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
Who cannot join
- Prior diagnosis or treatment of prostate cancer
- Inability to undergo prostate MRI
- Inability to receive MRI contrast agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.
Read the detailed description
Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. Prostate cancer has substantial inherited predisposition and men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer. Men with specific genetic variants, such as pathogenic BRCA2 mutations, are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer. However, the penetrance of many mutations in prostate cancer risk genes is unknown, and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer. Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected. The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam, PSA, and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations, identify potentially novel genetic risk mutations and/or markers for early detection.
- Conditions
- Prostatic Neoplasm, Prostate Cancer, BRCA2 Mutation, BRCA1 Mutation, ATM Gene Mutation, MMR Mutation
- Being tested
- Prostate cancer screening
- Keywords
- BRCA2, BRCA1, Mismatch Repair Deficiency, Lynch Syndrome, HOXB13, Family History of Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Genetic Predisposition to Disease, Turcot syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate cancer screeningDiagnostic test
Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene Receives: Diagnostic Test: Prostate cancer screening | |
| Cohort B | Family history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes Receives: Diagnostic Test: Prostate cancer screening | |
| Cohort C | Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry Receives: Diagnostic Test: Prostate cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of prostate cancer
Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer
Measured: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first
Secondary outcomes (1)
Positive predictive value of multiparametric MRI for detection of prostate cancer
Positive predictive value of multiparametric prostate MRI for detecting clinically significant prostate cancer in men at high genetic risk for prostate cancer with a positive MRI (PI-RADS score of 3 or higher)
Measured: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start12 Feb 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keyan Salari, MD, PhD, Massachusetts General Hospital
- Investigators
- Keyan Salari, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129605
- Sponsor's protocol ID
- 2020P000081
- Acronym
- PROGRESS
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amini AE, Salari K. Incorporating Genetic Risk Into Prostate Cancer Care: Implications for Early Detection and Precision Oncology. JCO Precis Oncol. 2024 Feb;8:e2300560. doi: 10.1200/PO.23.00560.
PubMed 38412389Amini AE, Hunter AE, Almashad A, Feng AJ, Patel ND, O'Dea MR, McCormick SR, Rodgers LH, Salari K. Magnetic Resonance Imaging-based Prostate Cancer Screening in Carriers of Pathogenic Germline Mutations: Interim Results from the Initial Screening Round of the Prostate Cancer Genetic Risk Evaluation and Screening Study. Eur Urol Oncol. 2024 Dec;7(6):1358-1366. doi: 10.1016/j.euo.2024.01.015. Epub 2024 Mar 6.
PubMed 38453598
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
- ClinicalTrials.gov ID
- NCT05129605
- Acronym / sponsor ID
- PROGRESS / 2020P000081
- Conditions
- Prostatic Neoplasm, Prostate Cancer, BRCA2 Mutation, BRCA1 Mutation, ATM Gene Mutation, MMR Mutation
- Keywords
- BRCA2, BRCA1, Mismatch Repair Deficiency, Lynch Syndrome, HOXB13, Family History of Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 22 Nov 2021 (actual)
- 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.
This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.
Detailed description
Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. Prostate cancer has substantial inherited predisposition and men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer. Men with specific genetic variants, such as pathogenic BRCA2 mutations, are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer. However, the penetrance of many mutations in prostate cancer risk genes is unknown, and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer. Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected. The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam, PSA, and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations, identify potentially novel genetic risk mutations and/or markers for early detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: Prostate cancer screeningDocumented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene |
| Cohort B | – | Diagnostic Test: Prostate cancer screeningFamily history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes |
| Cohort C | – | Diagnostic Test: Prostate cancer screeningIndividuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men ages 35-74 years old at high genetic risk for prostate cancer on the basis of a specific germline genetic mutation or a strong family history.
Key inclusion criteria (7 listed)
- Men 35-74 years old
- No known diagnosis of prostate cancer
- Life expectancy >10 years
- Meet cohort A, B, or C criteria
- Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
Key exclusion criteria (3 listed)
- Prior diagnosis or treatment of prostate cancer
- Inability to undergo prostate MRI
- Inability to receive MRI contrast agent
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 |
|---|---|---|
| Prostate cancer screeningPhysical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate | Diagnostic test | Cohort A, Cohort B, Cohort C |
Primary outcome
Diagnosis of prostate cancer
Time frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first
Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer
1 secondary outcome
Positive predictive value of multiparametric MRI for detection of prostate cancer
Time frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 38412389Amini AE, Salari K. Incorporating Genetic Risk Into Prostate Cancer Care: Implications for Early Detection and Precision Oncology. JCO Precis Oncol. 2024 Feb;8:e2300560. doi: 10.1200/PO.23.00560.
- Results publication: PubMed 38453598Amini AE, Hunter AE, Almashad A, Feng AJ, Patel ND, O'Dea MR, McCormick SR, Rodgers LH, Salari K. Magnetic Resonance Imaging-based Prostate Cancer Screening in Carriers of Pathogenic Germline Mutations: Interim Results from the Initial Screening Round of the Prostate Cancer Genetic Risk Evaluation and Screening Study. Eur Urol Oncol. 2024 Dec;7(6):1358-1366. doi: 10.1016/j.euo.2024.01.015. Epub 2024 Mar 6.
- 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.
Keyan Salari, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasm and Prostate Cancer, run by Massachusetts General Hospital at 1 site 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olympia Price (857-238-3838, oprice@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of prostate cancer (time frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first). 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 NCT05129605, which also lists 2 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 9 Oct 2024.