Adenocarcinoma of the ProstatePhase 2NCT01498978

Ipilimumab in Combination With Androgen Suppression Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

A Phase 2 study testing ipilimumab and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer
What is being tested?: ipilimumab and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: 6 Feb 2012to 19 Jan 2019
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

Willing and able to give written informed consent
Histologic diagnosis of adenocarcinoma of the prostate
A PSA of > 0.2 ng/ml after 6-18 months of androgen suppression therapy, which may consist of luteinizing hormone-releasing hormone (LHRH) agonist or antagonist alone or the combination of an LHRH agonist or antagonist plus an antiandrogen, such as bicalutamide; androgen suppression therapy will continue without interruption
Radiographic evidence of regional or distant metastasis at the time of study enrollment or at the time of diagnosis
White blood cell (WBC) >= 2000/uL
Absolute neutrophil count (ANC) >= 1000/uL

Show all 19Show fewer

Platelets >= 50 x 10^3/uL
Hemoglobin >= 8 g/dL
Creatinine =< 3.0 x upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN for patients without liver metastasis
Bilirubin =< 3.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
No known active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; patients should be assessed for high risk behaviors that may result in these infections, such as intravenous drug use or multiple sexual partners; the assessment should be noted
Eastern Cooperative Oncology Group (ECOG) =< 1
Patients receiving any herbal product known to decrease PSA levels (i.e. saw palmetto and prostate cancer [PC]-SPES), or any immunosuppressive dose of systemic or absorbable topical corticosteroid (except prednisone up to 10 mg orally per [q] day, or its equivalent), must discontinue the agent for at least 2 weeks prior to screening; progressive disease must be documented after discontinuation of these products
Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to the first infusion with ipilimumab
Total testosterone < 50 ng/ml, except in patients with prior orchiectomy, where testosterone does not need to be measured; patients must continue their LHRH agonist therapy throughout study duration
Life expectancy >= 6 months; this must be documented
Patients who are sexually active with a partner who could become pregnant are to use an effective form of barrier contraception, such as condoms or a partner using oral contraceptive pills; persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 8 weeks after ipilimumab is stopped
If a patient enters the trial on androgen suppression therapy (AST) that consists of both an LHRH agonist and an oral antiandrogen, both agents should be continued throughout the study; if an antiandrogen is stopped prior to study entry, it should be stopped 4 weeks before for nilutamide and flutamide and 6 weeks before for bicalutamide to ensure that a withdrawal phenomenon does not interfere with interpretation of efficacy results

Who cannot join

Radiation to any area of the body < 28 days prior to randomization
Any other active malignancy with the exception of adequately treated basal or squamous cell skin cancer or superficial bladder cancer
Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. myasthenia gravis, Guillain-Barre syndrome); those with immune-mediated skin toxicity (i.e. toxic epidermal necrolysis, Stevens-Johnson syndrome) will also be excluded
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
A history of prior treatment with ipilimumab or prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or agonist
Concomitant therapy with any of the following: interleukin (IL)-2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents (over the counter [OTC]/herbal/prescribed); immunostimulant agents, other than the study agent; other investigational therapies; or chronic use of systemic corticosteroids (greater than prednisone 10 mg orally per day, or its equivalent)
Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e., infectious) illness

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
OHSU Knight Cancer Institute
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase II Study of CTLA Blockade by Ipilimumab Plus Androgen Suppression Therapy in Patients With an Incomplete Response to AST Alone for Metastatic Prostate Cancer

This phase II trial studies how well ipilimumab works when given together with androgen suppression therapy in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Androgen can cause the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal glands from making androgen. Giving ipilimumab together with androgen suppression therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

Proportion of patients who achieve an undetectable prostate-specific antigen (PSA) (=< 0.2 ng/ml) after initiation of ipilimumab therapy.

SECONDARY OBJECTIVES:

Time to PSA progression. II. Time to progression by any measure. III. Maximum percentage of PSA reduction in each patient. IV. Number of patients with immune related adverse events (IRAEs) and correlation of these with complete PSA response, time to progression, and T cell measurements.
Measures of T cell response to therapy with flow cytometry. VI. Response in measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

VII. Time to death from any cause. VIII. To examine correlative biomarkers and their relationship to clinical outcomes. Potential biomarkers include, but are not limited to C-reactive protein (CRP), insulin-like growth factor (IGF)-1 and -2, or follicle stimulating hormone (FSH).

XV. Bank samples for future molecular correlative studies, biomarker, or other studies.

OUTLINE:

Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Conditions: Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
Being tested: ipilimumab, laboratory biomarker analysis
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ipilimumabBiological
Also called anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, monoclonal antibody CTLA-4
Given IV
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01498978
Study group	Role	What they receive
Treatment (ipilimumab)	Experimental	Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses. Receives: Biological: ipilimumab; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml)
Undetectable PSA (prostate-specific antigen) defined as PSA ≤ 0.2 ng/mg after initiation of ipilimumab therapy.
Provided with the exact 95% confidence interval. PSA response as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG2) definitions.
Percentage can take on values between 0% and 100%.
Measured: Up to 5 years

Secondary outcomes (10)

Time to PSA Progression
PSA (prostate-specific antigen) progression defined as a PSA increase of >= 25% and at least 2 ng/mL from baseline or nadir PSA achieved, confirmed by a second measurement at least three weeks later
Time to PSA progression is calculated as the time from Day 1 of combination therapy to first PSA measurement of >= 25% increase and at least 2 ng/mL above the nadir and confirmed by a second measurement at least three weeks later. For subjects without a PSA decline from baseline, time to PSA progression is calculated as the time from Day 1 of combination therapy to first PSA measurement of >= 25% increase and at least 2 ng/mL increase from baseline after 12 weeks and confirmed by a second measurement at least three weeks later.
Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval.
Measured: Up to 5 years
Time to Progression by Any Measure
Time to progression is calculated from Day 1 of combination therapy to first evidence of progression by any measure (PSA, Measurable Disease or Clinical Progression).
Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval.
Measured: Up to 5 years
Time to Death From Any Cause
Time to death is calculated from Day 1 of combination therapy to death from any cause.
Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval.
Measured: Up to 5 years
Number of Patients With IRAEs
Immune-Related Adverse Events (IRAEs) are defined as an adverse event (AE) of unknown etiology associated with drug exposure and consistent with an immune phenomenon
Tabulated for each treatment group and summarized according to major organ categories of the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Measured: Up to 6 months
Correlation Between IRAE and PSA Progression.
Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event. PSA (prostate-specific antigen) Progression is defined as a PSA increase of >= 25% and at least 2 ng/mL from Baseline, or Nadir PSA Achieved, confirmed by a second measurement at least three weeks later.
The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association.
Measured: Up to 5 years
Correlation of IRAEs With Ratio of T Regulatory Cells to T Effector Cells
Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.
Raw T cells data was collected, but has not been analyzed by the lab and will not be done due to constraints.
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to day 1 of course 4
Correlation Between IRAEs and Immune Response
Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.
Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis.
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to day 1 of course 4
Correlation Between IRAE and Radiographic Progression.
Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event. Radiographic progression is progression determined by scan.
The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association.
Measured: Up to 5 years
Correlation Between IRAE and Any Progression.
Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.
The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association.
Measured: Up to 5 years
Correlation Between IRAE and Overall Survival.
Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.
The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association.
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201219 Jan 2019

First posted26 Dec 2011 (estimated)
Study start6 Feb 2012
Primary completion28 Feb 2017
Study completion19 Jan 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
More trials run by OHSU Knight Cancer 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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01498978
Sponsor's protocol ID: IRB00005254
Other IDs: NCI-2011-03556, CA184059, 08-004, 5254
Status last verified: Sep 2020
First submitted: 20 Dec 2011
Last updated: 14 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Graff JN, Stein MN, Surana R, Al Rabadi L, Liu E, Fong L, Bailey S, Latour E, Newby TA, Moran AE, Beer TM. Phase II Study of Ipilimumab in Men With Metastatic Prostate Cancer With an Incomplete Response to Androgen Deprivation Therapy. Front Oncol. 2020 Aug 7;10:1381. doi: 10.3389/fonc.2020.01381. eCollection 2020.
PubMed 32850444

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
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Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
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All Adenocarcinoma of the Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of CTLA Blockade by Ipilimumab Plus Androgen Suppression Therapy in Patients With an Incomplete Response to AST Alone for Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT01498978
Acronym / sponsor ID: IRB00005254
Conditions: Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, Oregon Health and Science University
Study start: 6 Feb 2012 (actual)
Primary completion: 28 Feb 2017 (actual)
Study completion: 19 Jan 2019 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 18 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Proportion of patients who achieve an undetectable prostate-specific antigen (PSA) (=< 0.2 ng/ml) after initiation of ipilimumab therapy.

SECONDARY OBJECTIVES:

Time to PSA progression. II. Time to progression by any measure. III. Maximum percentage of PSA reduction in each patient. IV. Number of patients with immune related adverse events (IRAEs) and correlation of these with complete PSA response, time to progression, and T cell measurements.
Measures of T cell response to therapy with flow cytometry. VI. Response in measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

XV. Bank samples for future molecular correlative studies, biomarker, or other studies.

OUTLINE:

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (ipilimumab)	Experimental	Biological: ipilimumab, Other: laboratory biomarker analysisPatients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression then receive maintenance ipilimumab IV once every 3 months for 4 additional doses.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Willing and able to give written informed consent
Histologic diagnosis of adenocarcinoma of the prostate
A PSA of > 0.2 ng/ml after 6-18 months of androgen suppression therapy, which may consist of luteinizing hormone-releasing hormone (LHRH) agonist or antagonist alone or the combination of an LHRH agonist or antagonist plus an antiandrogen, such as bicalutamide; androgen suppression therapy will continue without interruption
Radiographic evidence of regional or distant metastasis at the time of study enrollment or at the time of diagnosis
White blood cell (WBC) >= 2000/uL

Key exclusion criteria (8 listed)

Radiation to any area of the body < 28 days prior to randomization
Any other active malignancy with the exception of adequately treated basal or squamous cell skin cancer or superficial bladder cancer
Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. myasthenia gravis, Guillain-Barre syndrome); those with immune-mediated skin toxicity (i.e. toxic epidermal necrolysis, Stevens-Johnson syndrome) will also be excluded
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)

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
ipilimumabAlso: anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, monoclonal antibody CTLA-4Given IV	Biological	Treatment (ipilimumab)
laboratory biomarker analysisCorrelative studies	Other	Treatment (ipilimumab)

Primary outcome

Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml)
Time frame: Up to 5 years
Undetectable PSA (prostate-specific antigen) defined as PSA ≤ 0.2 ng/mg after initiation of ipilimumab therapy. Provided with the exact 95% confidence interval. PSA response as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG2) definitions. Percentage can take on values between 0% and 100%.

10 secondary outcomes

Time to PSA Progression
Time frame: Up to 5 years
Time to Progression by Any Measure
Time frame: Up to 5 years
Time to Death From Any Cause
Time frame: Up to 5 years
Number of Patients With IRAEs
Time frame: Up to 6 months
Correlation Between IRAE and PSA Progression.
Time frame: Up to 5 years
Correlation of IRAEs With Ratio of T Regulatory Cells to T Effector Cells
Time frame: Up to day 1 of course 4
Correlation Between IRAEs and Immune Response
Time frame: Up to day 1 of course 4
Correlation Between IRAE and Radiographic Progression.
Time frame: Up to 5 years
Correlation Between IRAE and Any Progression.
Time frame: Up to 5 years
Correlation Between IRAE and Overall Survival.
Time frame: Up to 5 years

Results and safety

Results posted to the registry on 18 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Ipilimumab)	10	8

Primary outcome: Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml)

Time frame: Up to 5 years. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Treatment (Ipilimumab) n = 10
Value	0.0 (0.0 to 0.0)

Population analysed: Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the start of Ipilimumab therapy until off study for progression, adverse event or other reason, an average of one year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Ipilimumab)	1 of 10 (10%)	10 of 10 (100%)	2 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32850444Graff JN, Stein MN, Surana R, Al Rabadi L, Liu E, Fong L, Bailey S, Latour E, Newby TA, Moran AE, Beer TM. Phase II Study of Ipilimumab in Men With Metastatic Prostate Cancer With an Incomplete Response to Androgen Deprivation Therapy. Front Oncol. 2020 Aug 7;10:1381. doi: 10.3389/fonc.2020.01381. eCollection 2020.

Related trials for Adenocarcinoma of the Prostate

RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma

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.

Julie Graff principal investigator

OHSU Knight Cancer Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 18 May 2018). 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?

Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01498978, which also lists 1 linked publication.

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 14 Oct 2020.