A proactive care plan may help men with prostate cancer live better

NCT ID NCT06865547

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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