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AzTrials

Advanced Prostate Adenocarcinoma With Neuroendocrine DifferentiationPhase 2NCT02893917

Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer

A Phase 2 study testing Cediranib and Olaparib in people with Advanced Prostate Adenocarcinoma With Neuroendocrine Differentiation and Castration-Resistant Prostate Carcinoma, run by National Cancer Institute (NCI) at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase II trial studies how well olaparib with or without cediranib works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). PARPs are proteins that help repair DNA mutations. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Cediranib and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
16 sitesUnited States
Study dates
11 Aug 2017to 31 May 2027
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

  • Patients must have histologically confirmed progressive, metastatic castration resistant prostate adenocarcinoma by meeting ALL the following:
  • Pathology of prostate gland or metastatic disease must confirm the diagnosis of prostate adenocarcinoma; mixed histology with other variants including but not limited to small cell or neuroendocrine differentiation must be discussed with the study principal investigator (PI)
  • Metastasis must be documented by radiographic evidence
  • Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/dL (< 2.0 nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to cycle 1, day 1 and must be continued throughout the study
  • Progression must be evidenced and documented by any of the following parameters
  • Two consecutively rising PSA values, above the baseline, at a minimum of 1-week intervals; the minimal value to enter the study is 1.0 ng/ml or greater; the reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met, if values 3A or #4 are 1 ng/mL or higher (Prostate Cancer Working Group 3)
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  • Appearance of one or more new lesions on bone scan
  • Progressive disease by RECIST 1.1
  • Must have a tumor lesion safely accessible for biopsy per the investigator's discretion; while a soft tissue metastasis is preferred for a biopsy, a bone metastasis is allowed for biopsy as long as enough cores can be obtained; a biopsied lesion cannot be used for target lesion for response assessment
  • Must be agreeable to the mandatory research tumor biopsies (pre-treatment and on-treatment); tumor biopsies are mandatory at pre-treatment and at on-treatment; there is an optional biopsy at post-progression
  • Must have received at least one prior line of therapy for mCRPC; a taxane chemotherapy administered for metastatic castration sensitive disease will not count, unless patient develops disease progression within 12 months from the last dose chemotherapy
  • Must have a life expectancy greater than or equal to 16 weeks
  • If patient is currently on prednisone or other corticosteroids for palliation, the dose must be less than or equal to 10 mg a day or its equivalent dose and it must have been started at least 4 weeks prior to cycle 1 day 1
  • Patients must have measurable disease by RECIST v1.1, or evaluable disease with bone metastases demonstrated by Tc99 bone scan; patients with bone metastases only are allowed (NOTE: nodes >= 1.5 cm (not >= 2 cm) in the short axis are considered measurable, per The Prostate Cancer Working Group 3 [PCWG3])
  • Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; patients with long-standing stable grade 2 neuropathy or others (e.g., adrenal insufficiency or hypothyroidism on stable doses of replacement therapy) may be allowed after discussion with the study principal investigator (PI)
  • Age >= 18 years. There is no dosing or adverse event data currently available on the use of cediranib or olaparib in patients < 18 years of age, thus excluding them from enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 70%)
  • White blood count (WBC) > 3 x 10^9/L (within 28 days prior to administration of study treatment)
  • Absolute neutrophil count >= 1,500/mcL (within 28 days prior to administration of study treatment)
  • Platelets >= 100,000/mcL (within 28 days prior to administration of study treatment)
  • Hemoglobin >= 10 g/dL with no pack red blood cell transfusion in the past 28 days (within 28 days prior to administration of study treatment)
  • Creatinine clearance >= 51 mL/min, calculated using Cockcroft-Gault formula (within 28 days prior to administration of study treatment)
  • Urine protein: creatinine ratio (UPC) of =< 1 (within 28 days prior to administration of study treatment)
  • Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3 times institutional ULN unless liver metastases are present in which case they must be < 5 x ULN (within 28 days prior to administration of study treatment)
  • Coagulation parameters (international normalized ratio [INR] and activated partial thromboplastin time [aPTT]) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed, or except patients on anticoagulation (within 28 days prior to administration of study treatment)
  • Patients must be able to swallow oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
  • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction; patients can be on thyroid hormone replacement medication; asymptomatic patients with elevated thyroid-stimulating hormone (TSH) with normal T4/T3 are allowed to enroll, and recommended to follow with routine thyroid function test especially if they are randomized to cediranib/olaparib arm
  • Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol
  • Patients must be willing and able to check and record daily blood pressure readings when randomized to cediranib containing arm
  • Patients must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution's lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months prior to registration if they have any of the following risk factors for cardiac toxicities:
  • A New York Heart Association (NYHA) classification of II controlled with treatment
  • Prior central thoracic radiation therapy (RT), including RT to the heart
  • History of myocardial infarction within 12 months prior to registration
  • Prior treatment with anthracyclines
  • Prior treatment with trastuzumab
  • Prior history of other significant impaired cardiac function
  • Male participants and their female partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination (see below for acceptable methods), and not to donate sperm, throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner; acceptable methods of contraception to be used in this study include:
  • Condom with spermicide and one of the following:
  • Oral contraceptive or hormonal therapy (e.g. hormone implants)
  • Placement of an intra-uterine device
  • Acceptable non-hormonal birth control methods include:
  • Total sexual abstinence; abstinence must be for the total duration of the study and the drug washout period
  • Vasectomized sexual partner plus male condom; with participant assurance that partner received post-vasectomy confirmation of azoospermia
  • Tubal occlusion plus male condom with spermicide
  • Intrauterine device (IUD) plus male condom+spermicide; provided coils are copper-banded
  • Acceptable hormonal methods:
  • Etonogestrel implants (e.g., Implanon, Norplan) + male condom with spermicide
  • Normal and low dose combined oral pills + male condom with spermicide
  • Norelgestromin/ethinyl estradiol (EE) transdermal system + male condom with spermicide
  • Intravaginal device + male condom with spermicide (e.g., EE and etonogestrel)
  • Cerazette (desogestrel) + male condom with spermicide; cerazette is currently the only highly efficacious progesterone based pill
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy, hormonal therapy (except LHRH agonist or antagonist), immunotherapy, radioisotope therapy, or RT within 21 days prior to start of the study agents
  • Initiating bisphosphonate, or RANKL antibody therapy or adjusting the dose/regimen within 30 days prior to cycle 1 day 1 is prohibited; patients on a stable bisphosphonate regimen are eligible and may continue
  • Patients who have received any other investigational agents within the past 28 days prior to cycle 1 day 1
  • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans are excluded from this clinical trial; while screening brain MRI is not required, it should be performed if clinically indicated at the discretion of the treating investigator; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study
  • For patients with known and treated brain metastases is allowed in this study if they fulfill ALL of the following criteria:
  • The lesions have remained radiologically stable for at least six weeks after completion of brain irradiation or stereotactic brain radiosurgery, and must remain stable at the time of study entry
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  • There is no mass effect present radiologically and no steroids requirement for symptom control for more than 4 weeks
  • Patients who have received a prior inhibitor of vascular endothelial growth factor (VEGF) signaling inhibitor, or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor administered
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib
  • Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir), moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil), strong CYP3A inducers (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil); a minimum washout period of 2 weeks prior to cycle 1 day 1 is required for strong inhibitors, and at least one week for moderate inhibitors; a minimum washout period of 4 weeks prior to cycle 1 day 1 is required for CYP3A inducers; a minimum washout period of 5 weeks prior to cycle 1 day 1 is required for enzalutamide or phenobarbital; dihydropyridine calcium-channel blockers are permitted for management of hypertension
  • Current use of natural herbal products or other "folk remedies"; if using previously, patients must stop using natural herbal products while participating in this study; multivitamin, calcium (Ca)/vitamin D (Vit D) and other vitamin complex supplements are allowed
  • Patients with concomitant or prior invasive malignancies within the past 5 years; subjects with limited stage basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast, or non-muscle invasive bladder cancer, are eligible as long as they received curative intent therapy
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled seizures 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
  • Resting ECG with corrected QT (QTc) > 470 msec on two or more time points within a 24 hour period, noted within 14 days of treatment, or family history of long QT syndrome
  • History of myocardial infarction within 6 months of the randomization
  • History of stroke or transient ischemic attack within 6 months of the randomization
  • NYHA classification of III or IV
  • Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows
  • History of hypertensive crisis or hypertensive encephalopathy within 3 years of the randomization
  • Clinically significant peripheral vascular disease or known abdominal aortic aneurysm ( > 5 cm in diameter) or history of aortic dissection; patients with known history of abdominal aortic aneurysm (AAA) with >= 4 cm in diameter, a repeat ultrasound (US) within the last 6 months prior to randomization will be required to document that it is =< 5 cm, and patient must be asymptomatic from the aneurysm, and the blood pressure must be well controlled as required in this protocol
  • A major surgical procedure, open biopsy, or significant traumatic injury within 3 months prior to cycle 1 day 1 (percutaneous/endobronchial/endoscopic biopsies are allowed)
  • History of bowel obstruction within 1 month prior to starting study drugs
  • History of hemoptysis within the last 1 month prior to randomization
  • Presence of cavitation of central pulmonary lesion, or radiographic evidence of pneumonitis or other extensive bilateral lung disease such as interstitial lung disease
  • Any history of gastrointestinal (GI) perforation, history of intra-abdominal abscess within 3 months prior to starting treatment, or history of abdominal fistula unless the fistula history meets all the following: (a) the fistula was surgically repaired, (b) there has been no evidence of fistula for at least 6 months prior to starting treatment, (c) patient is deemed to be at low risk of recurrent fistula, and (d) the case must be discussed with the study PI
  • Current dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)
  • Known coagulopathy or bleeding diathesis; those on therapeutic anticoagulation or anti-platelet agent are permitted only after discussing with the study PI
  • Patients with history of intra-abdominal bleeding or retroperitoneal bleeding within the last 3 years are excluded
  • Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), or features suggestive of MDS/AML
  • Patients with known active human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; it is because of the potential requirement for anti-viral therapies that are prohibited on the study; patients with a history of hepatitis B or hepatitis C, who are deemed cured and no longer require treatment may be allowed to enroll after consultation with the respective specialist and the study PI
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
  • Whole blood transfusions in the last 120 days prior to entry to the study
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Previous enrollment in the present study

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Randomized Phase 2 Study of Cediranib in Combination With Olaparib Versus Olaparib Alone in Men With Metastatic Castration Resistant Prostate Cancer

This randomized phase II trial studies how well olaparib with or without cediranib works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving olaparib and cediranib may help treat patients with castration-resistant prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the clinical activity of the combination of cediranib and olaparib, as measured by radiographic progression free survival (rPFS), as compared to olaparib monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC).

SECONDARY OBJECTIVES:

  1. To assess the clinical activity of the combination of cediranib and olaparib, as measured by prostate-specific antigen (PSA) response rate, radiographic response rate by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, and overall survival (OS), as compared to olaparib monotherapy in patients with mCRPC.

II. To evaluate association of homologous recombination deoxyribonucleic acid (DNA) repair deficiency (HRD) with the clinical activity of the combination of cediranib and olaparib or olaparib monotherapy, as measured by rPFS, in mCRPC patients.

III. To evaluate the safety the combination of cediranib and olaparib and olaparib monotherapy in patients with metastatic prostate cancer.

EXPLORATORY OBJECTIVES:

  1. To characterize genomic alterations by whole exome sequencing in mCRPC patients and correlate that with clinical activity or resistance to olaparib with or without cediranib.

II. To characterize changes in ribonucleic acid (RNA) expression of DNA repair genes, angiogenesis markers, and immune markers, by whole transcriptome sequencing and correlate with clinical activity or resistance to olaparib with or without cediranib.

III. To characterize changes in immune tumor microenvironment in mCRPC patients by profiling expression of co-stimulatory and co-inhibitory molecules and tumor infiltrating lymphocytes, and correlate with clinical activity or resistance to olaparib with or without cediranib.

IV. To identify baseline predictive biomarkers for rPFS or response and to identify on-treatment markers of acquired resistance in men with mCRPC receiving either olaparib plus cediranib or olaparib alone.

  1. To explore biomarker signatures that correlate with the clinical activity or resistance to olaparib with or without cediranib, including changes in gene expression or acquired mutations in tumor biopsies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive olaparib orally (PO) twice daily (BID) and cediranib PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.

Being tested
Cediranib, Olaparib
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • CediranibDrug

    Also called AZ-D2171, AZD 2171, AZD2171

    Given PO

  • OlaparibDrug

    Also called AZD 2281, AZD-2281, AZD2281, KU 0059436

    Given PO

Study groups in NCT02893917
Study groupRoleWhat they receive
Arm A (olaparib, cediranib)ExperimentalPatients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cediranib; Drug: Olaparib
Arm B (olaparib)Active comparatorPatients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Olaparib

What is being measured

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

  1. Radiographic Progression Free Survival

    The two study arms will be compared for radiographic progression free survival with Kaplan-Meier estimates and log-rank tests. The Rothman confidence interval, which is based on Greenwood's variance, Thomas and Grunkemeier confidence interval, and the simultaneous confidence bands by Nair and Hall and Wellner, will be reported. In addition, the possible confounding variables will be compared for survival with log-rank test.

    Measured: Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed up to 5 years

Secondary outcomes (6)

  1. Overall Survival

    Will use the rank preserving structure failure time model for the overall survival analysis.

    Measured: Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 5 years

  2. Objective Response Rate

    Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. The exact 95% confidence interval of objective response rate will be reported based on the binomial distribution. The multivariate data analysis will be completed using the logistic regression model. The adjusted p-value and adjusted 95% confidence interval will also be reported.

    Measured: Up to 5 years

  3. Prostate-specific Antigen Response Rate

    Prostate-specific antigen response will be defined by prostate-specific antigen decline from baseline > 50%, confirmed by a second value at 3-4 weeks later. Prostate-specific antigen response rate analysis will be based on a subset of patients who had prostate-specific antigen progression prior to enrollment. The multivariate data analysis will be completed using the logistic regression model.

    Measured: Up to 5 years

  4. Correlation Between Homologous Recombination Deficiency Status and Radiographic Progression Free Survival

    Homologous recombination deficiency positive status is defined by presence of homozygous deletion or deleterious mutations in key homologous recombination genes of deoxyribonucleic acid repair genes as analyzed by BROCA-homologous recombination test. The data analysis will be completed using log rank Test. The multivariate data analysis will be completed using the Cox PH model.

    Measured: Up to 1 week prior to start of therapy

  5. Incidence of Genomic Alterations

    Will be assessed by whole exome sequencing and transcriptome sequencing. The biomarker data analysis will be completed using Lasso-based elastic net method.

    Measured: Up to 5 years

  6. Incidence of Adverse Events

    Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 will be effective by April 1, 2018). Descriptive statistics, including means, standard deviations, and ranges for continuous parameters, as well as percentages and frequencies for categorical parameters, will be presented. Adverse medical events will be tabulated. NCI toxicity grade 3 and grade 4 laboratory abnormalities will be listed and tabled. At the time of results reporting, presented are the count of participants in either arm that experienced at least 1 adverse event.

    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.

  1. First posted9 Sep 2016 (estimated)
  2. Study start11 Aug 2017
  3. Primary completion14 Mar 2023
  4. Study completion31 May 2027 (estimated)

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02893917
Sponsor's protocol ID
NCI-2016-01346
Other IDs
NCI-2016-01346, 2000020461, 9984, 9984, UM1CA186689
Status last verified
Jun 2026
First submitted
8 Sep 2016
Last updated
31 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kim JW, McKay RR, Radke MR, Zhao S, Taplin ME, Davis NB, Monk P, Appleman LJ, Lara PN Jr, Vaishampayan UN, Zhang J, Paul AK, Bubley G, Van Allen EM, Unlu S, Huang Y, Loda M, Shapiro GI, Glazer PM, LoRusso PM, Ivy SP, Shyr Y, Swisher EM, Petrylak DP. Randomized Trial of Olaparib With or Without Cediranib for Metastatic Castration-Resistant Prostate Cancer: The Results From National Cancer Institute 9984. J Clin Oncol. 2023 Feb 1;41(4):871-880. doi: 10.1200/JCO.21.02947. Epub 2022 Oct 18.

    PubMed 36256912

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cediranib and Olaparib in people with Advanced Prostate Adenocarcinoma With Neuroendocrine Differentiation and Castration-Resistant Prostate Carcinoma, run by National Cancer Institute (NCI) at 16 sites 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 53 inclusion and 34 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 30 Mar 2025). 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?

Radiographic Progression Free Survival (time frame: Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed 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 NCT02893917, 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 31 Jul 2026.

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