Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Recruiting
Phase 3
Interventional Study
Metastatic Prostate Cancer
Intermitent Anti-androgen Therapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 – 80
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Other
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About This Trial
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for this study:
1. Male aged ≥18 years;
2. Histologically or cytologically confirmed prostate adenocarcinoma;
3. Metastatic disease (confirmed by conventional imaging);
4. ECOG performance status of 0-1;
5. Suitabl…
Contacts