Clinical trial · Observational
Molecular Stratification Profiling Protocol in Metastatic Castration Resistant Prostate Cancer (mCRPC) - MAESTRO
MAESTRO: Molecular Stratification Profiling Protocol in Metastatic Castration Resistant Prostate Cancer (mCRPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, observational, molecular stratification profiling study. Patients with mCRPC who have received at least one standard treatment for mCRPC will be approached to participate in MAESTRO. Patients must have archival tumour available and be willing to undergo a fresh tumour biopsy for molecular analyses. Tumour tissue (archival and fresh), research blood samples and saliva will be sent to the central laboratory for analysis to identify molecular aberrations through targeted or broader molecular analyses (e.g. exome, transcriptome) and orthogonal assays (e.g. immunohistochemistry; digital droplet PCR). When the results are available, depending on patients choice, the results will be discussed. If significant results are indicated, patients will be recommended to have follow up with a cancer geneticist to discuss the implications of these results for their personal and family's health. There is a safety follow up 30 days after collection of study biopsy or blood samples. Patients will also be followed up for overall survival and subsequent anticancer treatment every 6 monthly via medical notes or telephone calls.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of molecular aberrations in diagnostic archive and fresh mCRPC tissue
- timeFrame
- 4-6 weeks
- description
- The prevalence of molecular aberrations in diagnostic archive and fresh mCRPC will be calculated with 95% confidence intervals.
Secondary outcomes (5)
- measure
- Quantify the association between molecular aberrations and baseline prognostic characteristics
- timeFrame
- 4-6 weeks
- description
- The association between identified molecular aberrations and baseline characteristics, known to be prognostic factors, will be quantified. Associations will be determined using Fisher's exact test for categorical characteristics and for continuous characteristics either a Wilcoxon rank sum test or t test will be used depending on the results of normality testing.
- measure
- Changes in molecular aberrations
- timeFrame
- 4-6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male aged ≥18 years. 2. Histologically confirmed metastatic castrate resistant adenocarcinoma of the prostate 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2. 4. Surgically or medically castrated, with testosterone levels of \<50 ng/dL (\<2.0 nM). 5. Confirmed metastatic disease on imaging. 6. Patients with tumour deemed by the designated investigator as safely suitable for fresh biopsy AND who are medically fit (according to local practice) to undergo a biopsy or procedure to acquire tumour tissue AND previously collected tumour specimens from prior surgery or biopsy available for analyses. An mCRPC biopsy collected within 6-months of trial entry can be used instead of this fresh biopsy if available and passes laboratory quality control requirements. 7. Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy. 8. The subject is capable of understanding and complying with the protocol requirements and has given written informed consent. Exclusion Criteria: 1. The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy. 2. Any psychiatric illness/social situations that would limit compliance with study requirements. 3. Presence of any concurrent condition or situation, which, in the investigators opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.
References
Publications (0)
Data not yet available