PROFILE Çalışması: Germline Genetik Profilleme: Hedefe Yönelik Prostat Kanseri Taraması ve Tedavisi ile İlişkisi

Sade dilde özet

Bu çalışma, germline (kalıtsal) genetik profillemenin, hedefe yönelik prostat kanseri (prostate cancer) taraması ve tedavisi ile ilişkisini araştırmaktadır; katılımcılara prostat MR ve biyopsi uygulanmaktadır. Çalışmaya, prostat kanseri aile öyküsü olan, siyahi Afrika veya Afrika-Karayip kökenli ya da BRCA1, BRCA2, ATM, PALB2 gibi genlerde risk artıran mutasyon taşıyan 40-69 yaş arası erkekler katılabilmektedir. Çalışma faz uygulanmayan bir çalışma olarak yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

Institute of Cancer Research, United Kingdom

Müdahale

Prostate MRI and Biopsy

Başlangıç

09.03.2015

Tahmini bitiş

31.12.2026

Ülkeler

United Kingdom

İlgili genler

Merkezler

• Sutton, United Kingdom

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

Either:

1. Men of any ethnicity with a positive family history of PrCa defined as:

   * Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \<70 years
   * Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \<70 years
   * Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age

   Or
2. Men of black African or black African-Caribbean ancestry defined as:

   Both parents and all 4 grandparents being of either black African or black African-Caribbean ancestry.

   Or
3. Men of any ethnicity with a genetic predisposition to having prostate cancer e.g., being known to have inherited a gene mutation that increases risk of prostate cancer (e.g. BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in the study protocol); and/or being known to have a high polygenic risk score (PRS) (defined as being in the top tenth percentile prior to enrolment).

   * Age 40- 69 years
   * WHO performance status 0-2
   * Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule.

Exclusion Criteria:

* Previous cancer with a life expectancy of less than five years.
* Previous PrCa
* Negative biopsy within one year before recruitment
* Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy)
* Men with body mass index (BMI) 40 and above.
* Men with BMI 35 and above plus other co-morbidities.
* Contraindications to having an MRI (non-MRI compliant pacemakers, aneurysm clips, metallic cardiac valve/stent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia)
* Any significant psychological conditions that may be worsened or exacerbated by participation in the study