Metastatic Prostate CancerPhase 3NCT06177015
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
A Phase 3 study testing Darolutamide continuous and Darolutamide intermittent in people with Metastatic Prostate Cancer and Intermitent Anti-androgen Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
- What is being tested?
- Darolutamide continuous and Darolutamide intermittent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2023to 31 Dec 2027
- Phase
- Phase 3
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be eligible for this study:
- Male aged ≥18 years;
- Histologically or cytologically confirmed prostate adenocarcinoma;
- Metastatic disease (confirmed by conventional imaging);
- ECOG performance status of 0-1;
- Suitable for ADT and docetaxel treatment;
Show all 13Show fewer
- Good bone marrow, kidney, and liver function:
- 1. (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):
- 1. Hemoglobin (HB) ≥ 90g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5×109/L; 3. Platelets (PLT) ≥ 80×109/L; 2. (2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening):
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Total bilirubin (TBIL) ≤ 2.0 × ULN;
- Serum creatinine (Cr) ≤ 2.0×ULN;
- 7. Willing to participate in this study, sign an informed consent form, and have good compliance
Who cannot join
- No metastatic disease;
- Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer
- Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
- Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
- History of malignant tumors;
- Planned receipt of other anti-tumor treatment during the study treatment period;
Show all 10Show fewer
- Known allergy to the above drug components;
- Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;
- Refusal to sign the informed consent form;
- Investigator's opinion that the participant is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Shangqian Wang, M.D.,PhD., 68303186, wsq5501@126.com
Lixin Hua, M.D.
About this study
Official title: Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
Read the detailed description
Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment.
- When the patient reaches:
- PSA ≤ 0.2ng/ml
- Or PSA > 0.2ng/ml but with more that 90% decrease comparing baseline
- Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.
- When the patient:
- PSA > 0.2ng/ml and has not decreased by 90% compared to baseline
- Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months
- Being tested
- Darolutamide continuous, Darolutamide intermittent
- Keywords
- triple treatment regimen, mHPSC, Darolutemide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide continuousDrug
Also called Darolutamide
standard of care
Darolutamide intermittentDrug
Also called Darolutamide
experimental group
| Study group | Role | What they receive |
|---|---|---|
| Continuous treatment group | Active comparator | Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC Receives: Drug: Darolutamide continuous |
| Intermittent treatment group | Experimental | Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC. Receives: Drug: Darolutamide intermittent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression Free Survival
rPFS
Measured: 36 months
Overall Survival
OS
Measured: 36 months
Secondary outcomes (2)
Time to castration-resistant prostate cancer
Time to mCRPC
Measured: 36 months
Time to pain progression
TTPP
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start11 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two independent arms
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Lixin, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Lixxin Hua, Principal investigator, Urology Dpt, First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177015
- Sponsor's protocol ID
- 2023-SR-662
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT06177015
- Acronym / sponsor ID
- 2023-SR-662
- Keywords
- triple treatment regimen, mHPSC, Darolutemide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2023 (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.
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
Detailed description
Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment.
- When the patient reaches:
- PSA ≤ 0.2ng/ml
- Or PSA > 0.2ng/ml but with more that 90% decrease comparing baseline
- Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.
- When the patient:
- PSA > 0.2ng/ml and has not decreased by 90% compared to baseline
- Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two independent arms
| Arm | Type | Receives |
|---|---|---|
| Continuous treatment group | Active comparator | Drug: Darolutamide continuousDarolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC |
| Intermittent treatment group | Experimental | Drug: Darolutamide intermittentOnly ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male aged ≥18 years;
- Histologically or cytologically confirmed prostate adenocarcinoma;
- Metastatic disease (confirmed by conventional imaging);
- ECOG performance status of 0-1;
- Suitable for ADT and docetaxel treatment;
Key exclusion criteria (10 listed)
- No metastatic disease;
- Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer
- Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
- Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
- History of malignant tumors;
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 |
|---|---|---|
| Darolutamide continuousAlso: Darolutamidestandard of care | Drug | Continuous treatment group |
| Darolutamide intermittentAlso: Darolutamideexperimental group | Drug | Intermittent treatment group |
Primary outcome
Radiographic Progression Free Survival
Time frame: 36 months
rPFS
Overall Survival
Time frame: 36 months
OS
2 secondary outcomes
Time to castration-resistant prostate cancer
Time frame: 36 months
Time to pain progression
Time frame: through study completion, an average of 3 year
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 26 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
Lixxin Hua principal investigator
Urology Dpt, First Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darolutamide continuous and Darolutamide intermittent in people with Metastatic Prostate Cancer and Intermitent Anti-androgen Therapy, run by The First Affiliated Hospital with Nanjing Medical University 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 13 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 26 Dec 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shangqian Wang (+862568303186, wsq5501@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression Free Survival (time frame: 36 months). The study lists 2 primary outcomes in all. 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 26 Dec 2023.