Prostate Cancer (Adenocarcinoma)ProANCT06865547
ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide
An observational study of Prostate Cancer (Adenocarcinoma), run by Yonghong Li at 1 site in China.
Trial summary
This is a Phase 4, multi-center, single arm, open-label clinical study to evaluate whether participants with mHSPC treated with apalutamide will benefit from the 4A ProActive Management Model. The study will include a Screening Period of up to 14 days before assignment on Day 1 to establish study eligibility. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- The 4A ProActive Management Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to 30 Jan 2027
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with mHSPC treated with apalutamide
Who may be able to join
- Participant must be a man ≥ 18 years of age, at the time of signing the informed consent.
- Participants who are diagnosed of prostate adenocarcinoma as confirmed by the Investigator and intend to be prescribed by apalutamide.
- Androgen deprivation therapy (ie, medical or surgical castration) must have been started less than 3 months prior to screening.
- Participant will be initiated with apalutamide and androgen deprivation therapy.
- 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.
- Be able to swallow whole apalutamide tablets.
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- 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.
- 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.
- 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.
- Participants are capable of giving signed informed consent.
Who cannot join
- Pathological findings consistent with small cell, ductal or neuroendocrine carcinoma of the prostate.
- 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.
- Visceral (ie, liver or lung) metastases as only sites of metastases.
- Current evidence of any of the following:
- 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.
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- Gastrointestinal disorder affecting absorption.
- Active infection requiring systemic therapy such as human immunodeficiency virus.
- Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
- 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).
- Participant have known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (please refer to Investigator's Brochure).
- Prior novel hormone therapy or chemotherapy.
- Treatment with drugs known to lower the seizure threshold within 4 weeks prior to enrollment.
- Current or prior treatment with anti-epileptic medications for the treatment of seizures.
- 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.
- Any condition or situation that in the opinion of the Investigator, would preclude participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
This is a Phase 4, multi-center, single arm, open-label clinical study to evaluate whether participants with mHSPC treated with apalutamide will benefit from the 4A ProActive Management Model.
The study will include a Screening Period of up to 14 days before assignment on Day 1 to establish study eligibility. Participants will get 4A ProActive Management according to the protocol .
Read more
As the background disease treatment, participants will received apalutamide according to local label (240 mg, 4 × 60 mg tablets, orally once daily with or without food) with duration of at least 6 months. Participants will have a Safety Follow-Up Visit within 30 days after the Visit 7.
Participants will be monitored for safety, starting from the time of signing the informed consent until 30 days after the Visit 7. AEs including laboratory AEs will be graded and summarized using Version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- The 4A ProActive Management Model
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 4A ProActive Management ModelBehavioural
This model focuses on four key areas - Active Education, Active Prevention Strategies, Active Management, and Active Follow-up. Active Education involves providing patients with detailed information on treatment regimens, potential AEs, and self-care through verbal education, reminder cards, and direct counseling. Active Prevention Strategies aims to directly reduce risks through nursing care bundles that incorporate supportive medications, fall risk assessments, and dietary guidance. Active Management establishes robust protocols for early AE reporting, rapid treatment, and standardized order sets. Active Follow-up comprises additional outpatient visits, patient surveys, medication refill coordination, and pharmacist/nurse follow-up calls to closely monitor patient adherence and symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change of FACT-P total score after 6 months from baseline.The Fact-P is the Functional Assessment of Cancer Therapy-Prostate.The score range is 0-156 points. The higher the score is, the higher the quality of life of the subjects is.
The Fact-P is the Functional Assessment of Cancer Therapy-Prostate.The score range is 0-156 points. The FACT-P scale has a uniform calculation formula, which is obtained by summing up the scores of each subscale.FACT-P Total score=(PWB score)+ (SWB score) +(EWB score) + (FWB score) + (PCS score)。The higher the score is, the higher the quality of life of the subjects is.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start22 Jan 2025
- Primary completion27 Aug 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Yonghong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yonghong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865547
- Sponsor's protocol ID
- 2024-FXY-317
- Acronym
- ProA
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide
- ClinicalTrials.gov ID
- NCT06865547
- Acronym / sponsor ID
- ProA / 2024-FXY-317
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Yonghong LiUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, multi-center, single arm, open-label clinical study to evaluate whether participants with mHSPC treated with apalutamide will benefit from the 4A ProActive Management Model.
The study will include a Screening Period of up to 14 days before assignment on Day 1 to establish study eligibility. Participants will get 4A ProActive Management according to the protocol .
As the background disease treatment, participants will received apalutamide according to local label (240 mg, 4 × 60 mg tablets, orally once daily with or without food) with duration of at least 6 months. Participants will have a Safety Follow-Up Visit within 30 days after the Visit 7.
Participants will be monitored for safety, starting from the time of signing the informed consent until 30 days after the Visit 7. AEs including laboratory AEs will be graded and summarized using Version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with mHSPC treated with apalutamide
Key inclusion criteria (11 listed)
- Participant must be a man ≥ 18 years of age, at the time of signing the informed consent.
- Participants who are diagnosed of prostate adenocarcinoma as confirmed by the Investigator and intend to be prescribed by apalutamide.
- Androgen deprivation therapy (ie, medical or surgical castration) must have been started less than 3 months prior to screening.
- Participant will be initiated with apalutamide and androgen deprivation therapy.
- 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.
Key exclusion criteria (16 listed)
- Pathological findings consistent with small cell, ductal or neuroendocrine carcinoma of the prostate.
- 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.
- Visceral (ie, liver or lung) metastases as only sites of metastases.
- Current evidence of any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 4A ProActive Management ModelThis model focuses on four key areas - Active Education, Active Prevention Strategies, Active Management, and Active Follow-up. Active Education involves providing patients with detailed information on treatment regimens, potential AEs, and self-care through verbal education, reminder cards, and direct counseling. Active Prevention Strategies aims to directly reduce risks through nursing care bundles that incorporate supportive medications, fall risk assessments, and dietary guidance. Active Management establishes robust protocols for early AE reporting, rapid treatment, and standardized order sets. Active Follow-up comprises additional outpatient visits, patient surveys, medication refill coordination, and pharmacist/nurse follow-up calls to closely monitor patient adherence and symptoms. | Behavioural | – |
Primary outcome
To evaluate the change of FACT-P total score after 6 months from baseline.The Fact-P is the Functional Assessment of Cancer Therapy-Prostate.The score range is 0-156 points. The higher the score is, the higher the quality of life of the subjects is.
Time frame: 6 months
The Fact-P is the Functional Assessment of Cancer Therapy-Prostate.The score range is 0-156 points. The FACT-P scale has a uniform calculation formula, which is obtained by summing up the scores of each subscale.FACT-P Total score=(PWB score)+ (SWB score) +(EWB score) + (FWB score) + (PCS score)。The higher the score is, the higher the quality of life of the subjects is.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma), run by Yonghong Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the change of FACT-P total score after 6 months from baseline.The Fact-P is the Functional Assessment of Cancer Therapy-Prostate.The score range is 0-156 points. The higher the score is, the higher the quality of life of the subjects is. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.