CompletedNot Applicable

Prospective Multicentre Cohort Study PROREPAIR-B (mCRPC)

408 participantsStarted 2013-01-15

Plain-language summary

PROREPAIR is a prospective multicenter observational cohort study of unselected patients with metastatic Castration Resistant Prostate Cancer (mCRPC) with unknown germline mutational status at study entry and who are candidates to start 1st line treatment with any approved survival-prolonging agent. The study aims to evaluate the impact of aberrations in DNA-repair genes,(BRCA1, BRCA2, ATM and PALB2 and other genes) on cause-specific survival from the diagnosis of the metastatic castration resistant status and other outcomes.

Who can participate

Age range18 Years – 99 Years

SexMALE

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Inclusion criteria

✓. Provision of signed informed consent.
✓. Patients must be ≥18 years old.
✓. Histologically confirmed prostate cancer
✓. presence of metastatic disease according to Bone-, CT- and/or MRI-scan.
✓. Confirmed castration resistant prostate cancer defined as disease progression despite castrate levels of testosterone (\<0.5ng/mL) and either a continuous rise in the serum prostate-specific antigen (PSA) levels, the progression of preexisting disease and /or the appearance of new metastases. Patients must be maintained on aLHRH or have underwent bilateral orchiectomy.
✓. Eligible patients are due to start or have started first-line treatment with any approved survival-prolonging therapy for mCRPC within a period of 6 months from study entry.
✓. ECOG performance status ≤21.
✓. Unknown mutation carrier status at the study entry.

Exclusion criteria

✕. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
✕. Any prior medical history that according to the judgement of the investigator might interfere with the subject´s granting of informed consent or the safe execution of the procedures required in the study.

What they're measuring

Assessment of the impact of BRCA1, BRCA2, ATM, PALB2 germline mutations

Timeframe: 42 months

Trial details

NCT IDNCT03075735

SponsorCentro Nacional de Investigaciones Oncologicas CARLOS III

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-05

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