Hormone Sensitive Metastatic Prostate CancerPhase 2NCT05461261
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer
A Phase 2 study testing Docetaxel, Prednisolone Acetate and Platinum-based drugs in people with Hormone Sensitive Metastatic Prostate Cancer and DNA Damage Repair Deficiency, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Hormone Sensitive Metastatic Prostate Cancer, DNA Damage Repair Deficiency, Chemotherapy Effect
- What is being tested?
- Docetaxel, Prednisolone Acetate and Platinum-based drugs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 40 and ≤75 years of age.
- All patients must have been histologically diagnozed of prostate cancer.
- Metastatic disease confirmed by imaging: positive bone scan, or soft tissue or visceral metastases confirmed by abdominal/pelvic/chest contrast CT or MRI or PSMA PET-CT scan.
- Participants who were treated with androgen deprivation therapy (ADT) (LHRH agonist/antagonist or orchectomy) with or without first-generation anti-androgens within 12 weeks prior to random assignment must maintain serum testosterone castration levels, i.e., ≤50 ng/dL (≤ 1.75 nmol/L) during the study period. First-generation anti-androgens must be discontinued at least 1 day before the start of study therapy.
- Participants must carry one of the following DNA repair gene mutation: 1) HRR-related genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L; 2) Lynch syndrome-related genes: EPCAM, MLH1, MSH2, MSH6, PMS2.
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤1.
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- Patients must have adequate hematologic function, hepatic function and renal function within 28 days prior to registration.
- Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
- Sexually active male subjects and their partner must agree the use of condoms as an effective contraceptive method and to avoid sperm donation during the whole treatment and within 4 weeks after the end of treatment.
Who cannot join
- Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- Patients with brain/meningeal metastases are not eligible..
- Patients previously received any of the following treatments are not eligible: 1) LHRH agonists/antagonists within 12 weeks prior to the start of study therapy; 2) Second generation androgen receptor (AR) inhibitors, such as enzaluamine, dalotamide, apatamide, etc; 3) Cytochrome P17 enzyme inhibitors (e.g., abiraterone acetate or oral ketoconazole) as antitumor therapy for PCa; 4) Chemotherapy (including docetaxel) or immunotherapy for PCa; 5) Systemic corticosteroids > 10 mg/day equivalent dose of prednisone within 28 days prior to random assignment.
- Patients who were known to have hypersensitivity to any research drug or similar drug are not eligible.
- Patients received local treatments such as pre-focal treatment,radiotherapy and palliative endoscopic resection
- Patients with severe or uncontrolled concurrent infections are not eligible.
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- Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
- Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
- Patients with mental illness, mental disability or inability to give informed consent are not eligible.
Trial locations and contacts
1 site in 1 country.
Hongqian Guo, MD contact
China1 site, 1 recruiting
- Recruiting
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210000
Shun Zhang, 15050589789 ext. 15050589789, explorershun@126.com
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation
This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.
- Conditions
- Hormone Sensitive Metastatic Prostate Cancer, DNA Damage Repair Deficiency, Chemotherapy Effect, Chemotherapeutic Toxicity
- Being tested
- Docetaxel, Prednisolone Acetate, Platinum-based drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles.
Prednisolone AcetateDrug
5mg Prednisolone Acetate will be given orally twice a day during treatment.
Platinum-based drugsDrug
Platinum-based drugs will be given intravenously 70 mg/m2 every 3 weeks for 6 cycles. Cisplatin or carboplatin will be carefully chosen according to each patient's Creatinine Clearance.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel plus platinum | Experimental | Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles. Receives: Drug: Docetaxel; Drug: Prednisolone Acetate; Drug: Platinum-based drugs |
| Docetaxel alone | Active comparator | Docetaxel alone will be applied every 3 weeks for 6 cycles. Receives: Drug: Docetaxel; Drug: Prednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC. 1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG.
Measured: up to 3 years
Secondary outcomes (5)
Overall survival
The survival rate of participants during follow-up time.
Measured: up to 5 years
rPFS
Radiographic progression-free survival. The survival of participants without radiographic progression.
Measured: up to 5 years
Time to PSA progression
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
Measured: up to 5 years
Time to subsequent anti-tumor therapy
Time from end of treatment to the time when subsequent anti-tumor therapy is needed.
Measured: up to 5 years
Adverse events
All grades of adverse events will be recorded according to NCI CTCAE (v.5.0)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Sensitive Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Hongqian Guo, Study chair, Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University Locations: China, Jiangsu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461261
- Sponsor's protocol ID
- IUNU-PC-114
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation
- ClinicalTrials.gov ID
- NCT05461261
- Acronym / sponsor ID
- IUNU-PC-114
- Conditions
- Hormone Sensitive Metastatic Prostate Cancer, DNA Damage Repair Deficiency, Chemotherapy Effect, Chemotherapeutic Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jul 2022 (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 randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel plus platinum | Experimental | Drug: Docetaxel, Drug: Prednisolone Acetate, Drug: Platinum-based drugsDocetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles. |
| Docetaxel alone | Active comparator | Drug: Docetaxel, Drug: Prednisolone AcetateDocetaxel alone will be applied every 3 weeks for 6 cycles. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be ≥ 40 and ≤75 years of age.
- All patients must have been histologically diagnozed of prostate cancer.
- Metastatic disease confirmed by imaging: positive bone scan, or soft tissue or visceral metastases confirmed by abdominal/pelvic/chest contrast CT or MRI or PSMA PET-CT scan.
- Participants who were treated with androgen deprivation therapy (ADT) (LHRH agonist/antagonist or orchectomy) with or without first-generation anti-androgens within 12 weeks prior to random assignment must maintain serum testosterone castration levels, i.e., ≤50 ng/dL (≤ 1.75 nmol/L) during the study period. First-generation anti-androgens must be discontinued at least 1 day before the start of study therapy.
- Participants must carry one of the following DNA repair gene mutation: 1) HRR-related genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L; 2) Lynch syndrome-related genes: EPCAM, MLH1, MSH2, MSH6, PMS2.
Key exclusion criteria (10 listed)
- Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- Patients with brain/meningeal metastases are not eligible..
- Patients previously received any of the following treatments are not eligible: 1) LHRH agonists/antagonists within 12 weeks prior to the start of study therapy; 2) Second generation androgen receptor (AR) inhibitors, such as enzaluamine, dalotamide, apatamide, etc; 3) Cytochrome P17 enzyme inhibitors (e.g., abiraterone acetate or oral ketoconazole) as antitumor therapy for PCa; 4) Chemotherapy (including docetaxel) or immunotherapy for PCa; 5) Systemic corticosteroids > 10 mg/day equivalent dose of prednisone within 28 days prior to random assignment.
- Patients who were known to have hypersensitivity to any research drug or similar drug are not eligible.
- Patients received local treatments such as pre-focal treatment,radiotherapy and palliative endoscopic resection
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 |
|---|---|---|
| DocetaxelDocetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles. | Drug | Docetaxel alone, Docetaxel plus platinum |
| Prednisolone Acetate5mg Prednisolone Acetate will be given orally twice a day during treatment. | Drug | Docetaxel alone, Docetaxel plus platinum |
| Platinum-based drugsPlatinum-based drugs will be given intravenously 70 mg/m2 every 3 weeks for 6 cycles. Cisplatin or carboplatin will be carefully chosen according to each patient's Creatinine Clearance. | Drug | Docetaxel plus platinum |
Primary outcome
Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Time frame: up to 3 years
Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC. 1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG.
5 secondary outcomes
Overall survival
Time frame: up to 5 years
rPFS
Time frame: up to 5 years
Time to PSA progression
Time frame: up to 5 years
Time to subsequent anti-tumor therapy
Time frame: up to 5 years
Adverse events
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Hongqian Guo, MD contact
Hongqian Guo study chair
Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University Locations: China, Jiangsu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Prednisolone Acetate and Platinum-based drugs in people with Hormone Sensitive Metastatic Prostate Cancer and DNA Damage Repair Deficiency, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 9 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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shun Zhang, MD (15050589789, explorershun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC) (time frame: up to 3 years). 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 24 Oct 2022.