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Shortened 12 months duration of androgen receptor signalling agent in combination with androgen deprivation therapy in patients with low-volume castration-sensitive prostate cancer: a randomized Nationwide Study
EU CTIS ID: 2023-506698-36-00
What this study is testing
To evaluate whether the discontinuation of ARSIs 12 months after its initiation in low-volume metastatic castration-sensitive prostate cancer (mCSPC) patients with the possibility to restart treatment, is non-inferior to continued androgen receptor signaling inhibitors (ARSI), thereby sparing significant toxicity and costs
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and ≥18 years of age
- 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 beyond the spine or pelvis, or visceral disease (non-nodal). This has been assessed by either bone scan and computed tomography (CT), or PSMA-PET scan. Low-volume disease has subsequently been confirmed by the local (multidisciplinary) team after consideration of the available imaging results as per the standard imaging protocol for the site.
- 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
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 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
See the full eligibility criteria
- Male and ≥18 years of age
- 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 beyond the spine or pelvis, or visceral disease (non-nodal). This has been assessed by either bone scan and computed tomography (CT), or PSMA-PET scan. Low-volume disease has subsequently been confirmed by the local (multidisciplinary) team after consideration of the available imaging results as per the standard imaging protocol for the site.
- 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
- Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form
- 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.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.