Prostate CancerPhase 2NCT06060587
Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone
A Phase 2 study testing Docetaxel, ADT and Abiraterone in people with Prostate Cancer, run by Northwestern University at 1 site in United States.
Trial summary
This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Docetaxel, ADT and Abiraterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to 22 Dec 2030
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed PCa and imaging evidence of metastatic disease on CT, MRI, and/or bone scan. A PSMA PET scan may be used, but findings confirming metastatic disease (ex. A lymph node > 1 cm or a bone lesion) must be observed on the CT portion of the scan.
- Patients must have low volume metastatic disease per the CHAARTED [1, 2] criteria; Low volume is defined as metastasis in lymph nodes outside of the pelvis and/or boney lesions (< 4 boney lesions, none outside of the axial skeleton). No visceral metastasis allowed. Metastatic disease must be documented either by a positive bone scan, contrast-enhanced abdominal/pelvic/chest computed tomography (CT) scan, magnetic resonance imaging scan or a prostate-specific membrane antigen (PSMA) PET scan. If a PSMA PET scan is used, the CT portion must confirm lymph node enlargement > 1cm or evidence of sclerosis for boney lesions. Metastatic disease is defined as either malignant lesions in the bone and/or measurable lymph nodes above the aortic bifurcation. Only patients with non-regional lymph node metastases (M1a) and/or bone metastases (M1B) will be eligible.
- Patients must have measurable disease as determined per RECIST version 1.1 See protocol for the evaluation of measurable disease. Lymph nodes are measurable if the short axis diameter is ≥ 10mm.
- Patient must be candidates for ADT, docetaxel and abiraterone therapy per treating investigator's judgment.
- Patients may have started ADT (LHRH agonist/antagonist or orchiectomy) for ≤ 12 weeks before randomization, with or without first generation anti-androgen.
- Patients must exhibit a/an ECOG performance status of ≤ 1.
Show all 11Show fewer
- Patients must have adequate organ and bone marrow function as defined in the protocol.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- If a patient has known brain metastases, they must have received radiation per SOC to control disease to be eligible for this trial.
- The effects of abiraterone and docetaxel on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic: patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) nor donate sperm, from time of informed consent, for the duration of study participation, and for 3 months following completion of abiraterone and 6 months following completion of docetaxel therapy. Should a patient's partner become pregnant or suspect they are pregnant while patient's partner is participating in this study, patient's partner should inform their treating physician immediately.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior treatment with:
- LHRH agonist/antagonist started > than 12 weeks before randomization NOTE: Use of androgen deprivation therapy (ADT) prior to the diagnosis of metastatic disease is allowed (see Inclusion Criteria 3.1.5 \& Section 4 Treatment Plan for full information)
- Second generation ARPIs such as enzalutamide, ARN-509, abiraterone, other investigational AR inhibitors
- Cytochrome P17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer.
- Chemotherapy or immunotherapy for prostate cancer prior to randomization except as described in Inclusion criteria 3.1.5
- Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
Show all 27Show fewer
- Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
- Known hypersensitivity to any of the study drugs, study drug classes or excipients in the formation of any of the study drugs
- Contraindication to both CT and MRI contrast agent
- Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure
- Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
- Patients who are unable to swallow oral medication, have malabsorption syndrome, have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, small bowel resection) or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the oral bioavailability of any of the study drugs
- Patients with history of or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with history of or evidence of chronic hepatitis C virus (HCV) infection, must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable antiviral regimen and have a CD4 count ≥ 200/mcL.
- Patients with chronic liver disease with a need for treatment
- Prior systemic treatment with an azole drug (e.g., fluconazole, itraconazole) within 4 weeks of randomization,
- Concomitant use of strong CYP3A4 inhibitors (see Appendix C)
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
- Ongoing or active infection requiring systemic treatment
- Cardiac arrhythmia uncontrolled with medical management
- Any other illness or condition or clinical laboratory finding that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Major surgery within past 30 days
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of ADT + Abiraterone Versus ADT + Docetaxel + Abiraterone in Patients With Low Volume Metastatic Hormone Sensitive Prostate Cancer
This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC).
This is a phase II, randomized, open label study comparing first line therapy with Androgen Deprivation Therapy (ADT) + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC).
Read more
The hypothesis being asked in this trial is whether first line treatment with ADT plus an androgen receptor pathway inhibitor (abiraterone) as a doublet regimen compared to ADT plus an androgen receptor pathway inhibitor (abiraterone) and docetaxel, as a triplet regimen results in superior outcomes for patients with low volume mHSPC.
We plan to enroll patients with mHPSC that meet the CHAARTED criteria for low disease volume. Patients will be randomized 1:1 to either treatment arm:
- doublet arm: abiraterone +ADT or
- triplet arm: abiraterone + ADT + docetaxel.
All subjects must receive ADT of the Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy, started = 12 weeks before randomization.
Read the detailed description
Primary Objective:
- To assess Progression Free Survival (PFS) for each treatment arms (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
Secondary Objective:
- To assess Overall Survival (OS) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- To assess PSA Response Rate for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- To assess ORR with measurable disease at baseline for each treatment arm for (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- Assessment of Time to castration resistant prostate cancer for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- Assess time to initiation of subsequent anti-neoplastic therapy for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
Exploratory Objectives:
- Assess Quality of Life (QoL) via the FACT-P QoL assessment tool (Appendix A QoL Survey FACT-P) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in safety
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, ADT, Abiraterone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75 mg/m2 via IV
ADTDrug
Prior to randomization as part of standard of care.
AbirateroneDrug
1000 mg by mouth
| Study group | Role | What they receive |
|---|---|---|
| Triplet Arm | Experimental | Abiraterone+Docetaxel+ADT
Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle.
Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets.
Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.
ADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT. Receives: Drug: Docetaxel; Drug: ADT; Drug: Abiraterone |
| Doublet Arm | Active comparator | Abiraterone+ADT
Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle.
Treatment of abiraterone should start ≤14 days after patient randomization.
Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets.
Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion. Receives: Drug: ADT; Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Progression Free Survival (PFS)
Calculated the progression-free survival time as the time that elapses between the date of randomization and the day of first documented disease progression (per RECIST 1.1 or PCWG3) or death from any cause for all evaluable patients. PFS will be calculated based on the Kaplan-Meier estimates of PFS for each treatment arm (abiraterone+docetaxel+ADT compared to abiraterone+ADT).
Measured: Up to 1 year after completion of study treatment
Secondary outcomes (4)
Assess Overall Survival (OS)
To assess the OS, this is defined as the time from date of randomization until time to death from any cause for all evaluable patients. OS will be calculated based on the Kaplan-Meier estimates of OS.
Measured: Up to 1 year after completion of study treatment
Assess PSA Response Rate
The PSA level drawn 6 months (+/- 30 days) after randomization will be used to assess PSA response.
Measured: 6 months (+/- 30 days) after randomization
Assessment of Time to castration resistant prostate cancer
This endpoint will calculate the time to the development of castration resistance from date of randomization to the time of PSA progression with serum testosterone level being at ≤ 50 ng/ml
Measured: Up to 1 year after completion of study treatment
Assess time to compare for any difference in efficacy between arms
This endpoint will calculate the time to the initiation of the subsequent anti-neoplastic therapy for each treatment arm from the date of randomization to the date of initiation of the next (non-study) anti-neoplastic agent for prostate cancer.
Measured: Up to 1 year after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start19 Oct 2023
- Primary completion3 May 2024
- Study completion22 Dec 2030 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah Fenton, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060587
- Sponsor's protocol ID
- NU 23U08
- Other IDs
- NCI-2023-07135, STU00220128, P30CA060553
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2023
- Last updated
- 22 Oct 2025
- 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 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of ADT + Abiraterone Versus ADT + Docetaxel + Abiraterone in Patients With Low Volume Metastatic Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT06060587
- Acronym / sponsor ID
- NU 23U08
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 22 Dec 2030 (estimated)
- First posted
- 29 Sep 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.
This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC).
This is a phase II, randomized, open label study comparing first line therapy with Androgen Deprivation Therapy (ADT) + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC).
The hypothesis being asked in this trial is whether first line treatment with ADT plus an androgen receptor pathway inhibitor (abiraterone) as a doublet regimen compared to ADT plus an androgen receptor pathway inhibitor (abiraterone) and docetaxel, as a triplet regimen results in superior outcomes for patients with low volume mHSPC.
We plan to enroll patients with mHPSC that meet the CHAARTED criteria for low disease volume. Patients will be randomized 1:1 to either treatment arm:
- doublet arm: abiraterone +ADT or
- triplet arm: abiraterone + ADT + docetaxel.
All subjects must receive ADT of the Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy, started = 12 weeks before randomization.
Detailed description
Primary Objective:
- To assess Progression Free Survival (PFS) for each treatment arms (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
Secondary Objective:
- To assess Overall Survival (OS) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- To assess PSA Response Rate for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- To assess ORR with measurable disease at baseline for each treatment arm for (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- Assessment of Time to castration resistant prostate cancer for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- Assess time to initiation of subsequent anti-neoplastic therapy for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
Exploratory Objectives:
- Assess Quality of Life (QoL) via the FACT-P QoL assessment tool (Appendix A QoL Survey FACT-P) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy
- Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triplet Arm | Experimental | Drug: Docetaxel, Drug: ADT, Drug: AbirateroneAbiraterone+Docetaxel+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion. ADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT. |
| Doublet Arm | Active comparator | Drug: ADT, Drug: AbirateroneAbiraterone+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Treatment of abiraterone should start ≤14 days after patient randomization. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically or cytologically confirmed PCa and imaging evidence of metastatic disease on CT, MRI, and/or bone scan. A PSMA PET scan may be used, but findings confirming metastatic disease (ex. A lymph node > 1 cm or a bone lesion) must be observed on the CT portion of the scan.
- Patients must have low volume metastatic disease per the CHAARTED [1, 2] criteria; Low volume is defined as metastasis in lymph nodes outside of the pelvis and/or boney lesions (< 4 boney lesions, none outside of the axial skeleton). No visceral metastasis allowed. Metastatic disease must be documented either by a positive bone scan, contrast-enhanced abdominal/pelvic/chest computed tomography (CT) scan, magnetic resonance imaging scan or a prostate-specific membrane antigen (PSMA) PET scan. If a PSMA PET scan is used, the CT portion must confirm lymph node enlargement > 1cm or evidence of sclerosis for boney lesions. Metastatic disease is defined as either malignant lesions in the bone and/or measurable lymph nodes above the aortic bifurcation. Only patients with non-regional lymph node metastases (M1a) and/or bone metastases (M1B) will be eligible.
- Patients must have measurable disease as determined per RECIST version 1.1 See protocol for the evaluation of measurable disease. Lymph nodes are measurable if the short axis diameter is ≥ 10mm.
- Patient must be candidates for ADT, docetaxel and abiraterone therapy per treating investigator's judgment.
- Patients may have started ADT (LHRH agonist/antagonist or orchiectomy) for ≤ 12 weeks before randomization, with or without first generation anti-androgen.
Key exclusion criteria (27 listed)
- Prior treatment with:
- LHRH agonist/antagonist started > than 12 weeks before randomization NOTE: Use of androgen deprivation therapy (ADT) prior to the diagnosis of metastatic disease is allowed (see Inclusion Criteria 3.1.5 \& Section 4 Treatment Plan for full information)
- Second generation ARPIs such as enzalutamide, ARN-509, abiraterone, other investigational AR inhibitors
- Cytochrome P17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer.
- Chemotherapy or immunotherapy for prostate cancer prior to randomization except as described in Inclusion criteria 3.1.5
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 |
|---|---|---|
| Docetaxel75 mg/m2 via IV | Drug | Triplet Arm |
| ADTPrior to randomization as part of standard of care. | Drug | Doublet Arm, Triplet Arm |
| Abiraterone1000 mg by mouth | Drug | Doublet Arm, Triplet Arm |
Primary outcome
Assess Progression Free Survival (PFS)
Time frame: Up to 1 year after completion of study treatment
Calculated the progression-free survival time as the time that elapses between the date of randomization and the day of first documented disease progression (per RECIST 1.1 or PCWG3) or death from any cause for all evaluable patients. PFS will be calculated based on the Kaplan-Meier estimates of PFS for each treatment arm (abiraterone+docetaxel+ADT compared to abiraterone+ADT).
4 secondary outcomes
Assess Overall Survival (OS)
Time frame: Up to 1 year after completion of study treatment
Assess PSA Response Rate
Time frame: 6 months (+/- 30 days) after randomization
Assessment of Time to castration resistant prostate cancer
Time frame: Up to 1 year after completion of study treatment
Assess time to compare for any difference in efficacy between arms
Time frame: Up to 1 year after completion of study treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Sarah Fenton, MD, PhD principal investigator
Northwestern University
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, ADT and Abiraterone in people with Prostate Cancer, run by Northwestern University 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 11 inclusion and 27 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: withdrawn, as of the sponsor's last update on 22 Oct 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess Progression Free Survival (PFS) (time frame: Up to 1 year after completion of study treatment). 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 22 Oct 2025.