Cediranib for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
UC San Diego Moores Cancer Center, La Jolla, CA
Prostate Cancer+13 More
Cediranib - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a combination of olaparib and cediranib works better than olaparib alone in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic).

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • Cancer
  • Carcinoma, Neuroendocrine
  • Carcinoma
  • Adenocarcinoma
  • Carcinoma, Small Cell
  • Prostate Small Cell Neuroendocrine Carcinoma
  • Neoplasms
  • Advanced Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • Castration-Resistant Prostate Carcinoma
  • Metastatic Malignant Neoplasm in the Bone
  • Stage IV Prostate Adenocarcinoma AJCC v7
  • Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • refractory, metastatic hormone-refractory Prostate cancer
  • Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cediranib will improve 1 primary outcome, 6 secondary outcomes, and 2 other outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 2 weeks prior to start of therapy.

Baseline
Baseline predictive biomarkers by plasma angiome
Year 2
Overall survival
Year 2
Radiographic progression free survival
Week 2
Correlation between homologous recombination deficiency status and radiographic progression free survival
Up to 2 years
Incidence of genomic alterations
Objective response rate
On-treatment markers of acquired resistance by plasma angiome
Prostate-specific antigen response rate
incidence of adverse events

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B (olaparib)
Arm A (olaparib, cediranib)

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cediranib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A (olaparib, cediranib)Patients 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.
Arm B (olaparib)
Drug
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib
Not yet FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

UC San Diego Moores Cancer Center - La Jolla, CA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have a serum testosterone level of less than 50 ng/dL (2.0 nmol/L) to be considered castration resistant show original
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. show original
The patient must have received at least two lines of therapy for mCRPC, and a taxane chemotherapy administered for metastatic castration sensitive disease will not count, unless the patient develops disease progression within 12 months from the last dose of chemotherapy. show original
The appearance of one or more new lesions on a bone scan may be a sign of cancer. show original
A disease that is progressing under the criteria of the RECIST 1.1 measurement system. show original
The diagnosis of prostate cancer must be confirmed with pathology of the prostate gland or metastatic disease show original
of distant tumor The presence of metastasis must be confirmed by radiographic evidence of a distant tumor. show original
Progression must be evidenced and documented by any of the following parameters
An accessible tumor lesion for biopsy is required, although a soft tissue metastasis is preferred show original
The mandatory research tumor biopsies must be agreeable to the patient; tumor biopsies are mandatory at pre-treatment and at on-treatment; there is an optional biopsy at post-progression. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is prostate cancer?

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Prostate cancer is a form of cancer that forms in the prostate gland. Men with prostate cancer are typically diagnosed after they are diagnosed with a low grade form of prostate cancer. Some men with high stage prostate cancer develop bone metastasis. When it affects males in the US the average life span following prostate cancer is 4-5 years.\nprostate cancer question: Does acupuncture increase prostate specific antigen levels in men with and without prostate cancer? answer: Acupuncture alone does not affect serum PSA levels in healthy men and the short-term clinical effectiveness of acupuncture should not be used as a marker or surrogate for prostate cancer.

Unverified Answer

What are common treatments for prostate cancer?

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The initial treatment of localized [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) includes simple observation or watchful waiting. Lifestyle changes such as exercise may positively influence outcomes from prostate cancer as well as reduce cancer-related morbidity and mortality. Lifestyle modification and exercise may also help prevent prostate cancer.

Unverified Answer

Can prostate cancer be cured?

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These data, obtained from the use of a number of prospective control groups with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) disease, suggest that the likelihood of the patient's disease remaining in the body after treatment is greater than in any other cancer. This has ramifications on patients' fears regarding cancer cure, and the likelihood of people accepting cancer treatment regimes that would result in the deaths of patients without cure.

Unverified Answer

What causes prostate cancer?

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As prostate cancer is diagnosed at relatively late stages, prevention methods should include health care education about the prevention, early diagnosis, and treatment of prostate cancer. A low-fat, low-calorie, and low-sugar diet seems reasonable.

Unverified Answer

What are the signs of prostate cancer?

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As we see in every tumor center and referral center the signs are variable. In our opinion there are two essential clues, a prostatic mass, and palpable prostatic veins. A prostatic mass may have other features. A palpable prostatic vein indicates metastatic disease from other locations. Tumor-derived PSA can be seen in up to 20% of cases.

Unverified Answer

How many people get prostate cancer a year in the United States?

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Approximately 474,200 men will be diagnosed with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) a year in the United States. Over 70% of those diagnosed will be screened by biopsy or autopsy. Prostate cancer remains a major health concern for men, and has accounted for 30% of all cancer deaths in the United States each year.

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

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Although the exact treatment plans for patients with prostate cancer are largely determined by factors such as the patient's specific and individual characteristics, advances in diagnostics and therapy have significantly benefited patients with prostate cancer, and improved outcomes and quality of life. The treatment options for prostate cancer depend on the extent and type of the initial disease, progression to metastatic disease from castrate-responsive disease, and overall patient prognosis.

Unverified Answer

What are the chances of developing prostate cancer?

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Men should be asked about previous exposure to other cancers and their treatment details including hormone replacement therapy (HRT). A risk is present for prostate cancer for patients who have never used HRT. This may be especially so if the patient has a family history of prostate cancer or a family history of colorectal cancer has occurred. Other risk factors include smoking, excess body weight, alcoholism, low physical activity, and diabetes. A previous negative screening result, a positive screening result or, for men previously diagnosed with prostate cancer, a risk factor. However, many physicians are unfamiliar with the concept of prostate cancer risk, so it is important for patients and their physicians.

Unverified Answer

What are the latest developments in cediranib for therapeutic use?

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New drug development results for cediranib were promising. Cediranib may decrease PSA levels, with fewer side effects compared with sunitinib or sorafenib. Censure analyses from Novartis must acknowledge that the development of these agents is still under way at the time the report was written. Future trials may need to include a direct comparison of cediranib with current therapeutics before any firm conclusions regarding cediranib can be drawn.

Unverified Answer

What is the average age someone gets prostate cancer?

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Men diagnosed with prostate cancer at age 60 years and over are more likely to have a family history of the disorder. A higher mortality rate is noted at this age of the patient, which is attributed to death from prostate cancer in the later stages of life.

Unverified Answer

Has cediranib proven to be more effective than a placebo?

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Cediranib is well tolerated in [metastatic [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)](https://www.withpower.com/clinical-trials/metastatic-prostate-cancer) patients who received prior chemotherapy, and provides a meaningful survival benefit compared with a placebo. Therefore, patients with metastatic prostate cancer should be offered cediranib in clinical trials. Because cediranib might be approved for locally advanced or metastatic cancers after prior chemoradiation, it may be useful for patients with localized prostate cancer as well as for those with unresectable local disease who are unsuitable for definitive radiotherapy.

Unverified Answer

What is cediranib?

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Cediranib is the first FDA-approved dual PI3K/mTOR inhibitor. This potent inhibitor of proliferation and cell migration is an exciting novel oral agent that can reverse the growth stimulators that are typically co-opted by all mTOR kinases, including those expressed by the EGFR and IGF1-R, and is therefore a potential option for the treatment of a wide variety of different cancers.

Unverified Answer
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