Castration-Sensitive Prostate CarcinomaPhase 2NCT03649841
Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer
A Phase 2 study testing Antiandrogen Therapy, Abiraterone Acetate and Prednisone in people with Castration-Sensitive Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-Sensitive Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma
- What is being tested?
- Antiandrogen Therapy, Abiraterone Acetate and Prednisone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 1 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologically proven (either histologic or cytologic) diagnosis of prostate adenocarcinoma with < 50% neuroendocrine differentiation or small cell histology.
- At least one site of nodal or distant metastatic disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or a bony metastasis that is evaluable on both computed tomography (CT) and bone scan.
- No prior orchiectomy.
- No androgen deprivation therapy such as treatment with antiandrogens, luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least one year prior to trial enrollment, and testosterone must be inside normal range prior to trial enrollment if there is prior history of ADT.
- No other systemic anti-cancer therapy for at least 1-year prior to enrollment.
- Prior prostate-directed therapies such as prostatectomy or cryotherapy are allowed.
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- Prior radiation treatments are allowed (prostate or metastatic sites) but must have been completed at least 3 months prior to starting ADT for this trial.
- White blood cell (WBC) > 3000/mm^3.
- Absolute neutrophil count (ANC) > 1000/mm^3.
- Platelets > 100,000/mm^3.
- Creatinine < 1.5 institutional upper limit of normal (ULN) or calculated creatinine clearance > 30 ml/min.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 3 x institutional ULN (unless patient has documented Gilbert's syndrome).
- No steroids for at least 2 weeks prior to enrollment, and patient must not be expected to require steroids during the study period, other than the typical low dose steroid that is given with abiraterone (typically prednisone or prednisolone at 5 mg twice daily).
- Zubrod performance status 0-2.
- Patient must sign study specific informed consent prior to study entry.
- Men who are sexually active must use medically acceptable forms of contraception.
Who cannot join
- Other illnesses with a life expectancy of less than 6 months, including but not limited to unstable angina, symptomatic congestive heart failure, cardiac arrhythmias.
- Psychological or social issues that would prevent patients from informed consent or complying with study requirements.
- Subject has a history of unexplained loss of consciousness or transient ischemic attack within 12 months of treatment start.
- Individuals on active treatment for a different cancer are excluded. Individuals with a history of other malignancies are eligible if they are deemed by the investigator to be at low risk for recurrence of that malignancy.
- Known brain metastasis.
- Known allergies, hypersensitivity, or intolerance to abiraterone or prednisone.
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- Prior ADT less than a year, or greater than two months, prior to trial enrollment or prior ADT with testosterone less than normal.
- There is a potential drug interaction when abiraterone is concomitantly used with a CYP2D6 substrate narrow therapeutic index (e.g., thioridazine, dextromethorphan), or strong CYP3A4 inhibitors (e.g., atazanavir, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) or strong inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine). Caution should be used when patients are on one of these drugs.
- Patients with a history of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis, human immunodeficiency virus (HIV), or chronic liver disease are not eligible.
- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses
This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking the production and interfering with the action of hormones. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy may work better in treating patients with prostate cancer.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for 6 months.
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Small Cell Neuroendocrine Carcinoma, Stage IV Prostate Cancer AJCC v8
- Being tested
- Antiandrogen Therapy, Abiraterone Acetate, Prednisone, Radiation Therapy
- 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.
Antiandrogen TherapyDrug
Also called ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy
Undergo ADT
Abiraterone AcetateDrug
Also called 17-(3-Pyridyl)-5,16-androstadien-3beta-acetate, 154229-18-2, Yonsa, Zytiga
Undergo Abiraterone Acetate Treatment SOC
PrednisoneDrug
Also called 10023, Delta 1-Cortisone
Undergo Prednisone Treatment SOC
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo neutron radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ADT, abiraterone, prednisone) | Active comparator | Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Antiandrogen Therapy; Drug: Abiraterone Acetate; Drug: Prednisone |
| Arm II (ADT, abiraterone, prednisone, radiation therapy) | Experimental | Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Antiandrogen Therapy; Drug: Abiraterone Acetate; Drug: Prednisone; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Peripheral Blood Effector T-cells (CCR7-/CD45RO)
Percent change in peripheral blood effector T-cells will be calculated by measuring the difference of the percent peripheral blood effector T-cells for each patient between two time points: pre-treatment and post-treatment (3 months after start of ADT, which is also 1 month post-radiation in the radiation arm). Unpaired two-sample t-test or Wilcoxon rank-sum test, depending on distribution of the percent change, will be used to test the null hypothesis that the percent change in peripheral blood effector T-cells is equal between the two arms.
Measured: Baseline to 3 months after start of antiandrogen therapy (ADT)
Secondary outcomes (2)
Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)
The number of patients with undetectable PSA at 6-months will be summarized by each arm and all combined.
Measured: At 6 months after start of abiraterone acetate
Incidence of Adverse Events
Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness of adverse events. Toxicities will be summarized as the number of patients with grade 3 or higher toxicities per CTCAE v4.0, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients, and per treatment arm.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start29 Jun 2020
- Primary completion1 Sep 2022
- Study completion1 Feb 2023
Why it stopped: Terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Castration-Sensitive Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jing Zeng, University of Washington
- Investigators
- Jing Zeng, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649841
- Sponsor's protocol ID
- RG1001784
- Other IDs
- NCI-2018-01548, 9938, P50CA097186
- Status last verified
- Oct 2023
- First submitted
- 22 Aug 2018
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses
- ClinicalTrials.gov ID
- NCT03649841
- Acronym / sponsor ID
- RG1001784
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Small Cell Neuroendocrine Carcinoma, Stage IV Prostate Cancer AJCC v8
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking the production and interfering with the action of hormones. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy may work better in treating patients with prostate cancer.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ADT, abiraterone, prednisone) | Active comparator | Drug: Antiandrogen Therapy, Drug: Abiraterone Acetate, Drug: PrednisonePatients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm II (ADT, abiraterone, prednisone, radiation therapy) | Experimental | Drug: Antiandrogen Therapy, Drug: Abiraterone Acetate, Drug: Prednisone, Radiation: Radiation TherapyPatients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically proven (either histologic or cytologic) diagnosis of prostate adenocarcinoma with < 50% neuroendocrine differentiation or small cell histology.
- At least one site of nodal or distant metastatic disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or a bony metastasis that is evaluable on both computed tomography (CT) and bone scan.
- No prior orchiectomy.
- No androgen deprivation therapy such as treatment with antiandrogens, luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least one year prior to trial enrollment, and testosterone must be inside normal range prior to trial enrollment if there is prior history of ADT.
- No other systemic anti-cancer therapy for at least 1-year prior to enrollment.
Key exclusion criteria (10 listed)
- Other illnesses with a life expectancy of less than 6 months, including but not limited to unstable angina, symptomatic congestive heart failure, cardiac arrhythmias.
- Psychological or social issues that would prevent patients from informed consent or complying with study requirements.
- Subject has a history of unexplained loss of consciousness or transient ischemic attack within 12 months of treatment start.
- Individuals on active treatment for a different cancer are excluded. Individuals with a history of other malignancies are eligible if they are deemed by the investigator to be at low risk for recurrence of that malignancy.
- Known brain metastasis.
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 |
|---|---|---|
| Antiandrogen TherapyAlso: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen TherapyUndergo ADT | Drug | Arm I (ADT, abiraterone, prednisone), Arm II (ADT, abiraterone, prednisone, radiation therapy) |
| Abiraterone AcetateAlso: 17-(3-Pyridyl)-5,16-androstadien-3beta-acetate, 154229-18-2, Yonsa, ZytigaUndergo Abiraterone Acetate Treatment SOC | Drug | Arm I (ADT, abiraterone, prednisone), Arm II (ADT, abiraterone, prednisone, radiation therapy) |
| PrednisoneAlso: 10023, Delta 1-CortisoneUndergo Prednisone Treatment SOC | Drug | Arm I (ADT, abiraterone, prednisone), Arm II (ADT, abiraterone, prednisone, radiation therapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo neutron radiation therapy | Radiation | Arm II (ADT, abiraterone, prednisone, radiation therapy) |
Primary outcome
Percent Change in Peripheral Blood Effector T-cells (CCR7-/CD45RO)
Time frame: Baseline to 3 months after start of antiandrogen therapy (ADT)
Percent change in peripheral blood effector T-cells will be calculated by measuring the difference of the percent peripheral blood effector T-cells for each patient between two time points: pre-treatment and post-treatment (3 months after start of ADT, which is also 1 month post-radiation in the radiation arm). Unpaired two-sample t-test or Wilcoxon rank-sum test, depending on distribution of the percent change, will be used to test the null hypothesis that the percent change in peripheral blood effector T-cells is equal between the two arms.
2 secondary outcomes
Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)
Time frame: At 6 months after start of abiraterone acetate
Incidence of Adverse Events
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jing Zeng principal investigator
University of Washington
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 Antiandrogen Therapy, Abiraterone Acetate and Prednisone in people with Castration-Sensitive Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by University of Washington 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 16 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: stopped early, as of the sponsor's last update on 26 Oct 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 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?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Peripheral Blood Effector T-cells (CCR7-/CD45RO) (time frame: Baseline to 3 months after start of antiandrogen therapy (ADT)). 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 Oct 2023.