Radium-223 in Biochemically Recurrent Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04206319|
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : March 15, 2021
Some men who have been treated for localized prostate cancer with surgery or radiation still show signs of the disease in their blood. This is called biochemically recurrent prostate cancer. Radium-223 is a small molecule. It uses radiation to kill cancer cells and improves survival in advanced prostate cancer. Researchers want to see if it can treat prostate cancer and induced immune changes earlier in the disease when the cancer is only detectable by prostate specific antigen (PSA) in the blood.
To learn how Radium-223 affects men with rising PSA but no evidence of cancer on conventional CT or bone scan, but positive findings on PET or molecular imaging in the bones. The primary focus is impact on the immune system with secondary focus on impact on PSA and imaging.
Men ages 18 and older with prostate cancer who have had surgery and/or radiation, but their PSA is rising even though no disease is visible on routine imaging scans (CT or bone scans). Patients are required to have PET or molecular imaging findings in bones, but not organs (lymph nodes are allowed).
Participants will be screened with a medical history and physical exam. Their ability to do normal tasks will be reviewed. They will give tissue samples or a report from their doctor about their cancer. They will have blood and urine tests. They will have an electrocardiogram to measure heart function. They will have a scan of their chest and abdomen using radiation or magnetic resonance imaging. They will have a bone scan with injection of Tc99. They will have a positron emission tomography scan with intravenous (IV) injection of 18F-NaF.
Participants will get Radium-223 by IV. For this, a small plastic tube is put into an arm vein. Radium-223 will be given on Day 1 of each cycle (1 cycle = 4 weeks) for up to 6 cycles. Participants will repeat the screening tests during the study. They will also complete Quality of Life Surveys and give stool samples.
After treatment, participants will have long-term follow-up every 6 weeks for the rest of their lives.
|Condition or disease||Intervention/treatment||Phase|
|Biochemical Recurrent Prostate Cancer||Drug: Radium-223 Drug: 18F Sodium Fluoride||Phase 2|
- Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy with either definitive radiation or surgery (biochemically recurrent prostate cancer). A primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.
- Radium-223 has demonstrated the ability to improve survival in men with symptomatic metastatic castration resistant prostate cancer (mCRPC) with a manageable toxicity profile, particularly in patients who have not yet received docetaxel.
- Radiation, even at low doses can impact immune recognition and immune cell killing of cancer cells. Recent findings by the LTIB suggest that radium-223 potentiated T-cell killing of prostate cancer cells.
- Radium-223 may present an alternative option for patients with BRPC that is not associated with substantial toxicity (as seen with ADT) and may have a lasting effect due to its potential effect on the immune system and/or the bone microenvironment.
- Emerging PET imaging studies will likely find evidence of "micrometastatic" disease, often in the bones, in biochemically recurrent prostate cancer patients, although these patients will have no standard of care that can be supported by prospective data.
- Radium-223 has demonstrated the ability to improve survival in men with symptomatic prostate cancer, but it remains unknown what the impact is in patients with "micrometastatic" or PET positive prostate cancer in their bones
- Preclinical data has suggested that radium-223 can impact the immune system.
- In addition, changes in PSA kinetics, changes on PET scan findings, and safety and tolerability of radium-223 in this population will also be evaluated.
- To determine statistically significant changes in immune cell populations compared to baseline in patients with biochemically recurrent or 18F NaF PET scan positive prostate cancer treated with radium-223
- Histologically confirmed adenocarcinoma of the prostate
- Patients with negative CT Scan and Tc-99m Bone Scan
- Patients with positive findings NaF PET imaging.
- Patients with a rise in PSA >= 0.8 ng/mL for patients following radical prostatectomy or for patients following definitive radiation therapy: a rise in PSA of >= 2 ng/mL above the nadir
- Patients with a PSA doubling time of 5-15 months
- ECOG 0-1
- Single arm study
- Patients will receive 6 injections of radium-223 with monthly assessments of PSA and periodic immune response. NaF PET scans will be completed at screening then at 4 and 7 months after the start of radium-223.
- After completion of treatment patient will be followed every 6 (+/- 2 weeks).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Radium-223 in Biochemically Recurrent Prostate Cancer|
|Actual Study Start Date :||September 22, 2020|
|Estimated Primary Completion Date :||November 15, 2021|
|Estimated Study Completion Date :||November 15, 2022|
Patients will receive radium-223 treatment every 4 weeks for up to 6 cycles. 18F-NaF PET scans will be used to assess response in bone.
An alpha particle-emitting drug, dose consistent of 55 kBq /kg (1.49 microcurie /kg); administered every 4 weeks.
Drug: 18F Sodium Fluoride
18F-NaF (Sodium Flouride) is a radio- pharmaceutical used to image skeletal pathology with positron emission tomography (PET) imaging.
- Changes in immune cell populations [ Time Frame: 6 months ]to determine the statistically significant changes in immune cell populations compared to baseline in patients with biochemically recurrent prostate cancer
- Changes in PSA kinetics [ Time Frame: 6 months ]rate of change in PSA per month
- Changes in PSA kinetics and the changes in immune cell populations relative to patients with similar disease undergoing a surveillance period on a similar protocol (NCT02649439) [ Time Frame: 6 months ]rate of change in PSA per month compared against those on the surveillance arm of 16-C-0035
- Safety and tolerability of radium-223 [ Time Frame: every 4 weeks ]type, number and frequency of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206319
|Contact: Amy R Hankin, P.A.-C||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Ravi A Madan, M.D.||National Cancer Institute (NCI)|