Metastatic Castration Sensitive Prostate CancerPhase 2NCT06734130
Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
A Phase 2 study testing Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI) and Docetaxel in people with Metastatic Castration Sensitive Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Sensitive Prostate Cancer
- What is being tested?
- Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI) and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to Jan 2029
- Phase
- Phase 2
- 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
Who may be able to join
- Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.
- No androgen deprivation therapy (ADT) with LHRH analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given > 2 years prior to the diagnosis of metastatic prostate cancer.
- Achieved >50% PSA decline and <4 ng/ml PSA after the run-in period.
- Adequate organ function with absolute neutrophil count > 1000/l, Hb > 10 g/dl, Platelet > 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal.
- No uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
- ECOG performance status 0-1.
- Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of ARSI or docetaxel administration.
- Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
- Surgical castration.
- Documented liver or brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
- Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
- Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of LHRH analog, or previously diagnosed with another malignancy \& have any evidence of residual disease. Patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with delayed healing of wounds, ulcers, and/or bone fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIA Study of Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.
- Being tested
- Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI), Docetaxel
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luteinizing Hormone-Releasing Hormone (LHRH) analogDrug
Also called Degarelix, Leuprolide, Triptorelin, Relugolix
The choice of the standard of care LHRH analog will be at the discretion of the treating physician.
Androgen Receptor Signal Inhibitor (ARSI)Drug
Also called Enzalutamide, Apalutamide, Darolutamide
The choice of the standard of care ARSI will be at the discretion of the treating physician.
DocetaxelDrug
Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Androgen Deprivation and Docetaxel Treatment | Experimental | This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period. Receives: Drug: Luteinizing Hormone-Releasing Hormone (LHRH) analog; Drug: Androgen Receptor Signal Inhibitor (ARSI); Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Castration Sensitivity Rate
Percentage of patients who remain castration sensitive at 36 months from initiation of LHRH analog for stage IV prostate cancer.
Measured: Up to 36 months
Secondary outcomes (4)
On treatment PSA Progression Free Survival
On treatment PSA progression free survival will be analyzed using the Kaplan-Meier method.
Measured: Up to 36 months
Radiographic Progression Free Survival
Radiographic progression free survival will be analyzed using the Kaplan-Meier method.
Measured: Up to 36 months
Overall Survival
Overall survival will be analyzed using the Kaplan-Meier method.
Measured: Up to 36 months
Patient Reported Outcome
Patient reported outcome as measured by National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index -17 items (NFPSI-17).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Jan 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingsong Zhang, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734130
- Sponsor's protocol ID
- MCC-23260
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIA Study of Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT06734130
- Acronym / sponsor ID
- MCC-23260
- Keywords
- Prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 16 Dec 2024 (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 prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Androgen Deprivation and Docetaxel Treatment | Experimental | Drug: Luteinizing Hormone-Releasing Hormone (LHRH) analog, Drug: Androgen Receptor Signal Inhibitor (ARSI), Drug: DocetaxelThis study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.
- No androgen deprivation therapy (ADT) with LHRH analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given > 2 years prior to the diagnosis of metastatic prostate cancer.
- Achieved >50% PSA decline and <4 ng/ml PSA after the run-in period.
- Adequate organ function with absolute neutrophil count > 1000/l, Hb > 10 g/dl, Platelet > 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal.
- No uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
Key exclusion criteria (8 listed)
- Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
- Surgical castration.
- Documented liver or brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
- Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
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 |
|---|---|---|
| Luteinizing Hormone-Releasing Hormone (LHRH) analogAlso: Degarelix, Leuprolide, Triptorelin, RelugolixThe choice of the standard of care LHRH analog will be at the discretion of the treating physician. | Drug | Adaptive Androgen Deprivation and Docetaxel Treatment |
| Androgen Receptor Signal Inhibitor (ARSI)Also: Enzalutamide, Apalutamide, DarolutamideThe choice of the standard of care ARSI will be at the discretion of the treating physician. | Drug | Adaptive Androgen Deprivation and Docetaxel Treatment |
| DocetaxelDocetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks. | Drug | Adaptive Androgen Deprivation and Docetaxel Treatment |
Primary outcome
Castration Sensitivity Rate
Time frame: Up to 36 months
Percentage of patients who remain castration sensitive at 36 months from initiation of LHRH analog for stage IV prostate cancer.
4 secondary outcomes
On treatment PSA Progression Free Survival
Time frame: Up to 36 months
Radiographic Progression Free Survival
Time frame: Up to 36 months
Overall Survival
Time frame: Up to 36 months
Patient Reported Outcome
Time frame: Up to 36 months
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 1 Apr 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.
Jingsong Zhang, MD, PhD principal investigator
Moffitt Cancer Center
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 Luteinizing Hormone-Releasing Hormone (LHRH) analog, Androgen Receptor Signal Inhibitor (ARSI) and Docetaxel in people with Metastatic Castration Sensitive Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 8 inclusion and 8 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 1 Apr 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 United States. 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?
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?
Castration Sensitivity Rate (time frame: Up to 36 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 1 Apr 2026.