ClinicaliQ Trial Snapshot
- Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer — Recruiting • Phase III • Oncology • NCT07751133.
- What is being tested: This phase 3 trial evaluates whether lower doses of Androgen Receptor Pathway Inhibitors (ARPIs) can achieve equivalent clinical effectiveness compared to standard doses in metastatic prostate cancer, whilst also assessing cost-effectiveness.
- Patient eligibility overview: The trial recruits patients with metastatic prostate cancer suitable for ARPI treatment, comparing lower-dose versus standard-dose hormone therapy regimens to determine optimal dosing strategies.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are: 1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and 2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose.…
Eligibility Snapshot
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- Adult males (male sex at birth) aged 18 years or older 2. Newly histologically or cytologically diagnosed prostate cancer (adenocarcinoma) that is metastatic hormone-sensitive (mHSPC) or metastatic castration resistant prostate cancer (mCRPC), for whom ARPI in combination with androgen deprivation is clinically planned 3. Prior ADT use for prostate cancer (including bilateral orchidectomy and transcutaneous oestrogen), is permitted provided: (a) ADT has been started less than 12 weeks prior to randomisation in mHSPC, (b) In the adjuvant setting the completion of adjuvant hormonal therapy was >12 months prior to randomisation and total duration is capped at 36 months total 4. ECOG performance status 0-2 5. Willing and able to give provide written informed consent.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.