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A Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants with mHSPC
EU CTIS ID: 2023-508607-20-00
What this study is testing
The primary objective is to determine if the addition of Apalutamide to androgen deprivation therapy (ADT) provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for subjects with mHSPC.
- 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
- Diagnosis of prostate adenocarcinoma as confirmed by the investigator
- Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
- Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
- Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
- Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy, lymph node dissection and systemic therapies
You likely can't join if
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- Known brain metastases
- Lymph nodes as only sites of metastases
- Visceral (ie, liver or lung) metastases as only sites of metastases
- Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or noninvasive superficial bladder cancer
- Prior treatment with other next generation antiandrogens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
See the full eligibility criteria
- Diagnosis of prostate adenocarcinoma as confirmed by the investigator
- Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
- Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
- Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
- Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy, lymph node dissection and systemic therapies
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- Known brain metastases
- Lymph nodes as only sites of metastases
- Visceral (ie, liver or lung) metastases as only sites of metastases
- Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or noninvasive superficial bladder cancer
- Prior treatment with other next generation antiandrogens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
- History of seizures or medications known to lower seizure threshold
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Korea, Republic of
- China
- Ukraine
- Russian Federation
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.
Where is this trial taking place?
Study sites include Canada; United States; Korea, Republic of; China; Ukraine; Russian Federation. 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 EU CTIS; the study team decides eligibility.