A proactive care plan may help men with prostate cancer live better
NCT ID NCT06865547
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests a proactive care model for men with metastatic hormone-sensitive prostate cancer who are taking the drug apalutamide. The model focuses on four areas: education, prevention, management, and follow-up, to help patients understand their treatment, reduce side effects, and stay on track. Researchers will measure changes in quality of life using a standard questionnaire after six months. The goal is to see if this extra support makes a meaningful difference in how patients feel day to day.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A behavioral care model called the 4A ProActive Management Model, which includes active education, prevention strategies, management, and follow-up, alongside the standard drug apalutamide.
- What this could lead to
- If it works, this care model could become a standard way to support men with this type of prostate cancer, helping them feel better and manage side effects more effectively.
- What could go wrong
- This is a single-arm study without a comparison group, so any benefit might not be proven. The outcome relies on patient-reported quality of life, which can vary for many reasons.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants with mHSPC treated with apalutamide
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant must be a man ≥ 18 years of age, at the time of signing the informed consent. 2. Participants who are diagnosed of prostate adenocarcinoma as confirmed by the Investigator and intend to be prescribed by apalutamide. 3. Androgen deprivation therapy (ie, medical or surgical castration) must have been started less than 3 months prior to screening. 4. Participant will be initiated with apalutamide and androgen deprivation therapy. 5. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (eg, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy. 6. Be able to swallow whole apalutamide tablets. 7. A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for at least 3 months after receiving the last dose of apalutamide. If the participant's partner is a person of childbearing potential, the participant must use condoms (with or without spermicide) and the sexual partner of the participant must also be practicing a highly effective method of contraception where conception is possible. A vasectomized participant must still use a condom (with or without spermicide) and the partner is also required to use a highly effective method of contraception where conception is possible. 8. A participant must agree not to donate sperm for the purposes of reproduction during the study and for at least 3 months after receiving the last dose of apalutamide. If applicable, participants should consider preservation of sperm prior to study treatment as anti cancer treatments may impair fertility. 9. A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of apalutamide. 10. Participants are capable of giving signed informed consent. Exclusion Criteria: 1. Pathological findings consistent with small cell, ductal or neuroendocrine carcinoma of the prostate. 2. Participant has active (new or progressive) brain metastases for whom the treating physician determines that central nervous system (CNS) specific treatment is required immediately or during the first cycle of therapy. Lymph nodes as only sites of metastases. Those with active (new or progressive) brain metastases for whom the treating physician determines that CNS specific treatment is not required immediately or during the first cycle of therapy are eligible for inclusion. 3. Visceral (ie, liver or lung) metastases as only sites of metastases. 4. Current evidence of any of the following: 1. Any of the following within 6 months prior to first dose of apalutamide: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease. 2. Gastrointestinal disorder affecting absorption. 3. Active infection requiring systemic therapy such as human immunodeficiency virus. 4. Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction 5. History of seizure or known condition that has been determined to significantly predispose to seizure per Investigator (including, but not limited to, loss of consciousness within 1 year prior to screening, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect). 6. Participant have known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (please refer to Investigator's Brochure). 7. Prior novel hormone therapy or chemotherapy. 8. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to enrollment. 9. Current or prior treatment with anti-epileptic medications for the treatment of seizures. 10. Administration of other investigational therapeutic agents, blood product support, growth factor support or invasive surgical procedure (not including surgical castration) ≤ 28 days prior to the first dose of apalutamide or currently enrolled in an investigational study. 11. Any condition or situation that in the opinion of the Investigator, would preclude participation in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic hormone sensitive prostate cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Mapping the tumor microenvironment to predict prostate cancer therapy outcomes
- Can a simple blood test outsmart prostate cancer?
- Half the dose, same hope? trial tests cutting hormone therapy in prostate cancer
- A sharper eye on prostate cancer: could new imaging spare healthy tissue?
- Can a new drug combo tame resistant prostate cancer?
- Virtual cooking classes aim to boost health for hispanic prostate cancer survivors and their families