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New treatment option for Prostate Cancer
Official title Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer
ClinicalTrials.gov ID: NCT07260435
What this study is testing
What is ADT plus only 12 months of ARPI?
ADT plus only 12 months of ARPI is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the outcomes of a shorter treatment duration (12 months) with an androgen receptor pathway inhibitor (ARPI), in this study Apalutamide or Enzalutamide, in patients with low-volume, hormone-sensitive metastatic prostate cancer (mCSPC), with the possibility to restart treatment if needed. The main research question is whether discontinuation of ARPI therapy after 12 months, with the option to restart treatment upon disease progression, is non-inferior to continued ARPI therapy, potentially reducing toxicity and costs.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male and ≥18 years of age
- Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form
- Histological diagnosis of prostate adenocarcinoma
- Low volume de novo metastatic disease (M1a or M1b) defined as anything other than fitting the criteria for high-volume metastatic disease, e.g., four...
- ADT initiated within 6 weeks prior to inclusion
You likely can't join if
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- Other prior malignancy less than or equal to 5 years prior to randomization except for squamous or basal cell skin carcinoma or non-invasive...
- History of seizures or medications known to lower seizure threshold
- Any other prior treatment for prostate cancer other than ADT (e.g., other next generation anti-androgens or other CYP17 inhibitors, chemotherapy...
- ADT started more than 6 weeks before inclusion
See the full eligibility criteria
- Male and ≥18 years of age
- Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form
- Histological diagnosis of prostate adenocarcinoma
- Low volume de novo metastatic disease (M1a or M1b) defined as anything other than fitting the criteria for high-volume metastatic disease, e.g., four or more bone lesions with one or more lesions in any body structure...
- ADT initiated within 6 weeks prior to inclusion
- Eastern Cooperative Oncology Group (ECOG) performance scale status of 0, 1 or 2
- Fit for treatment with apalutamide or enzalutamide according to treating physician
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- Other prior malignancy less than or equal to 5 years prior to randomization except for squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
- History of seizures or medications known to lower seizure threshold
- Any other prior treatment for prostate cancer other than ADT (e.g., other next generation anti-androgens or other CYP17 inhibitors, chemotherapy, immunotherapy, or radiopharmaceutical agents)
- ADT started more than 6 weeks before inclusion
The study team makes the final eligibility decision.
Where it's taking place
- Alkmaar, Netherlands
- Amersfoort, Netherlands
- Amsterdam, Netherlands
- Assen, Netherlands
- Beverwijk, Netherlands
- Deventer, Netherlands
- Eindhoven, Netherlands
- Emmen, Netherlands
- Enschede, Netherlands
- Goes, Netherlands
- Groningen, Netherlands
- Haarlem, Netherlands
- Hengelo, Netherlands
- Hilversum, Netherlands
- Leeuwarden, Netherlands
- Maastricht, Netherlands
- Nijmegen, Netherlands
- Roermond, Netherlands
- Roosendaal, Netherlands
- Rotterdam, Netherlands
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alkmaar, Netherlands; Amersfoort, Netherlands; Amsterdam, Netherlands; Assen, Netherlands; Beverwijk, Netherlands; Deventer, Netherlands and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.