VARIANT: A multicentre randomised feasibility trial of implementing a biomarker-guided personalised treatment in patients with advanced prostate cancer

Not Applicable

Completed

• Conditions: Advanced metastatic prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN10246848
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31857319 protocol (added 23/12/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37035713/ (added 28/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-12
• Study Completion: 2020-09-30
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
2. Radiographic and/or histological and/or cytological evidence of metastatic disease
3. Castrate levels of testosterone and documented ongoing medical or surgical castration. Testosterone level =50ng/dl /1.73 nmol/L and maintaining on androgen suppression therapy.
4. Disease progression since the last change in therapy defined by one or more of the following:
4.1. PSA progression as defined by the prostate cancer working group 3 (PCWG3) criteria. This must be based on a series of at least 3 readings, each at least 7 days apart demonstrating rising PSA. The 3rd reading must be = 2ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (i.e. the 3 readings do not need to be consecutive). The first of the three readings must have been obtained after commencing the previous systemic therapy, or, in the case of androgen receptor antagonists, after discontinuing
4.2. Bone disease progression as determined by the local radiology/ multidisciplinary team
4.3. Radiographic progression of nodal or visceral metastases as determined by the local radiology/ multidisciplinary team
5. Suitable for treatment with at least one novel hormonal treatment (with available treatments abiraterone acetate or enzalutamide) and one non-hormonal therapy (with available treatments docetaxel, cabazitaxel or radium-223). At least one of each type of treatment must be available to the patient
6. At least two high risk features
6.1. Age <60 years at time of diagnosis of metastatic disease
6.2. Bone metastases present at time of initial metastatic prostate cancer diagnosis (although not mandated, it is considered good clinical practice to have up to date imaging within 8 weeks)
6.3. Gleason grade group 4 or 5 (Gleason score 8 to 10)
6.4. Presence of visceral metastases (e.g. liver or lung) at any time point. This does not include lymph node metastases (although not mandated, it is considered good clinical practice to have up to date imaging within 8 weeks).
6.5. PSA doubling time < 3 months
6.6. Elevated alkaline phosphatase above institutional upper limit of normal
6.7. ECOG Performance Status worse than or equal to 1
6.8. Previous treatment for castration-resistant prostate cancer with docetaxel chemotherapy
6.9. Previous treatment for castration-resistant prostate cancer with abiraterone and/or enzalutamide or equivalent agent
7. Estimated life expectancy > 6 months
8. Aged 18 years or over
9. Provision of written informed consent, including consent for bio-banking of blood samples at the NICR

Exclusion Criteria

1. Histological variants of prostate cancers with small cell or neuroendocrine features
2. Prior or current malignancy (except adenocarcinoma of the prostate) with an estimated = 30% chance of relapse/progression within next 2 years
3. Previously identified brain metastases or spinal cord compression unless treated with full functional recovery
4. Administration of an investigational agent within 30 days of first dose of trial medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified