FDG-PET-Guided Radiation Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Northwestern University
Must be taking: Androgen deprivation therapy
Disqualifiers: Castration resistant prostate cancer, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.
Do I need to stop my current medications to join the trial?
The trial does not specify that you need to stop your current medications. In fact, it mentions that you will continue your standard treatment while participating in the study. However, any changes in your treatment due to side effects or other reasons should be discussed with the study team.
What data supports the effectiveness of the treatment FDG-PET-Guided Radiation Therapy for Prostate Cancer?
Research suggests that PET imaging, including FDG-PET, can help in identifying and targeting specific areas of prostate cancer, potentially improving the accuracy and effectiveness of radiation therapy. Although more studies are needed, PET imaging has shown promise in guiding individualized treatment and improving outcomes in prostate cancer management.
12345How is FDG-PET-guided radiation therapy different from other prostate cancer treatments?
FDG-PET-guided radiation therapy for prostate cancer is unique because it uses a special imaging technique (FDG-PET) to detect and target metastatic disease, potentially improving the precision of radiation therapy. This approach is particularly useful for identifying and treating metastatic lesions that might not be visible with standard imaging methods.
16789Eligibility Criteria
This trial is for men with prostate cancer that still responds to hormone therapy and has spread beyond the original site. Participants must be suitable for standard treatments, including antiandrogen therapy and chemotherapy. Specific details on inclusion or exclusion criteria are not provided.Inclusion Criteria
Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the endpoints for this study, in the opinion of the treating investigator, are eligible
Patients must have a life expectancy of at least 6 months, in the opinion of the treating investigator
+13 more
Exclusion Criteria
I started advanced prostate cancer treatment more than 26 weeks ago.
My prostate cancer is growing despite low testosterone levels.
I started hormone therapy for cancer more than 26 weeks ago but less than 1 year ago.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT, followed by MDRT for PET-avid disease
6 months
Multiple visits for scans and treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
36 months
Follow-up visits at 3 months, 6 months, and every 6 months thereafter
Participant Groups
The study compares FDG-PET-guided radiation therapy combined with standard treatments against standard treatments alone in metastatic hormone sensitive prostate cancer. The goal is to see if adding targeted radiation improves outcomes.
6Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2A (FDG-PET, MDRT, SOC ADT)Experimental Treatment5 Interventions
Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
Group II: Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)Experimental Treatment6 Interventions
Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial.
Group III: Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)Active Control5 Interventions
Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
Group IV: Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)Active Control5 Interventions
Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
Group V: Arm 2B (FDG-PET, SOC ADT)Active Control4 Interventions
Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
Group VI: Arm 2C (FDG-PET, SOC ADT)Active Control4 Interventions
Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
Northwestern Medicine: KishwaukeeDeKalb, IL
Northwestern Medicine: DelnorGeneva, IL
Northwestern Medicine Orland ParkOrland Park, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Stereotactic Radiotherapy for Lesions Detected via 68Ga-Prostate-specific Membrane Antigen and 18F-Fluorodexyglucose Positron Emission Tomography/Computed Tomography in Patients with Nonmetastatic Prostate Cancer with Early Prostate-specific Antigen Progression on Androgen Deprivation Therapy: A Prospective Single-center Study. [2022]Label="BACKGROUND">Dual-tracer positron emission tomography/computed tomography (PET/CT) with a 68Ga-labelled prostate-specific membrane antigen (PSMA) ligand and 18F-fluorodeoxyglucose (FDG) improves detection of metastatic heterogeneity and burden in patients with nonmetastatic prostate cancer (nmPCa). However, there is limited prospective evidence regarding its impact on the efficacy of stereotactic body radiotherapy (SBRT).
PET of Glucose Metabolism and Cellular Proliferation in Prostate Cancer. [2018]Imaging of the Warburg effect, which is the principal but not the sole cause for enhanced glucose metabolism in tumors, with PET and 18F-FDG has become the mainstay for the imaging evaluation of several cancers. Despite the seemingly prevalent notion that 18F-FDG PET may not be useful in prostate cancer, relatively limited evidence suggests that this imaging modality can be useful for the evaluation of the extent of metastatic disease and the assessment of the therapy response and prognosis in men with castration-resistant prostate cancer. Incidental high focal 18F-FDG uptake in the prostate gland, although generally rare, may also indicate occult prostate cancer that may need to be further scrutinized. In general, 18F-FDG PET is not useful for initial staging and is of limited utility in the clinical setting of biochemical failure after prior definitive therapy for primary cancer. Although more experience is needed, it appears that the imaging of cellular proliferation with PET and 3'-deoxy-3'-18F-fluorothymidine or 2'-18F-fluoro-5-methyl-1-β-d-arabinofuranosyluracil may also allow for targeted biopsy and localization for focal therapy of aggressive prostate tumors as well as assessment of the therapy response to various standard and novel treatment regimens in patients with metastatic disease.
Oligometastasis in Prostate Cancer: Can We Learn from Those "Excluded" from a Phase 2 Trial? [2023]We conducted and previously published a phase 2 trial of metastasis-directed therapy (MDT) in men with recurrence of prostate cancer at a low prostate-specific antigen level following radical prostatectomy and postoperative radiotherapy. All patients had negative conventional imaging and underwent prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Patients without visible disease (n = 16) or with metastatic disease not amenable to MDT (n = 19) were excluded from the interventional study. The remaining patients with disease visible on PSMA-PET received MDT (n = 37). We analyzed all three groups to identify distinct phenotypes in the era of molecular imaging-based characterization of recurrent disease. Median follow up was 37 mo (interquartile range 27.5-43.0). There was no significant difference in time to the development of metastasis on conventional imaging among the groups; however, castrate-resistant prostate cancer-free survival was significantly shorter for patients with PSMA-avid disease not amenable to MDT (p = 0.047). Our findings suggest that PSMA-PET findings can help in discriminating diverging clinical phenotypes among men with disease recurrence and negative conventional imaging after local therapies with curative intent. There is a pressing need for better characterization of this rapidly growing population of patients with recurrent disease defined by PSMA-PET to derive robust selection criteria and outcome definitions for ongoing and future studies.
Radiotherapy as metastasis-directed therapy for oligometastatic prostate cancer. [2022]To summarize the available literature regarding radiotherapy as a metastasis-directed therapy (MDT) in the treatment of oligometastatic prostate cancer (PCa).
PET guidance in prostate cancer radiotherapy: Quantitative imaging to predict response and guide treatment. [2017]Positron emission tomography (PET) allows a monitoring and recording of the spatial and temporal distribution of molecular/cellular processes for diagnostic and therapeutic applications. The aim of this review is to describe the current applications and to explore the role of PET in prostate cancer management, mainly in the radiation therapy (RT) scenario. The state-of-the art of PET for prostate cancer will be presented together with the impact of new specific PET tracers and technological developments aiming at obtaining better imaging quality, increased tumor detectability and more accurate volume delineation. An increased number of studies have been focusing on PET quantification methods as predictive biomarkers capable of guiding individualized treatment and improving patient outcome; the sophisticated advanced intensity modulated and imaged guided radiation therapy techniques (IMRT/IGRT) are capable of boosting more radioresistant tumor (sub)volumes. The use of advanced feature analyses of PET images is an approach that holds great promise with regard to several oncological diseases, but needs further validation in managing prostate diseases.
Diagnostic role of fluorodeoxyglucose positron emission tomography-computed tomography in prostate cancer. [2021]The role of fluorine-18 fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography (CT) in prostate cancer remains controversial due to a limited number of previous clinical investigations. The aim of the present retrospective study was to assess the diagnostic value of FDG PET-CT in prostate cancer, with an emphasis on the detection of metastatic disease. Twenty-five relevant cases of patients with newly diagnosed prostate cancer, referred for staging, or with a history of prostate cancer or recent prostate specific antigen (PSA) relapse, referred for the detection of metastatic disease, were included in the present study. None of the patients had known imaging or pathological evidence of metastatic disease prior to FDG PET-CT, however, the PSA levels had been recorded in all patients in the two months prior to FDG PET-CT imaging. Verification of the FDG PET-CT observations was made by biopsy, regional diagnostic CT and/or whole-body bone scintigraphy. The sensitivity of FDG PET-CT in identifying untreated primary lesions was only 33% (3/9). However, FDG PET-CT detected metastatic disease in six of the nine patients who underwent initial staging. Out of 16 patients with previous treatments and recent PSA relapse, FDG PET-CT successfully identified metastatic diseases in 12 and tumor recurrence within the prostatic fossa of two patients. The difference in the PSA levels was identified to be statistically significant between the FDG PET-CT-positive and -negative subgroups of the 16 restaging patients. The results indicated that FDG PET-CT is not useful for the diagnosis of prostate cancer, but may aid with the detection of metastatic disease in appropriately selected patients.
Radiation Therapy in Oligometastatic Prostate Cancer. [2022]Prostate cancer ranges from localized, low risk to metastatic, morbid disease. Although radiation therapy (RT) is commonly incorporated in the treatment of early disease or for palliation of symptomatic lesions, its role in extending survival in metastatic disease is less well-established. Here, we review the available evidence surrounding localized RT in the presence of oligometastatic disease and metastasis-directed therapy in both hormone-sensitive and hormone-resistant prostate cancer. We further outline potential future incorporation of RT as an immune-sensitizing therapy and the importance of highly sensitive imaging modalities in considering RT in metastatic disease.
Utility of Biology-Guided Radiotherapy to De Novo Metastases Diagnosed During Staging of High-Risk Biopsy-Proven Prostate Cancer. [2022]Biology-guided radiotherapy (BgRT) uses real-time functional imaging to guide radiation therapy treatment. Positron emission tomography (PET) tracers targeting prostate-specific membrane antigen (PSMA) are superior for prostate cancer detection than conventional imaging. This study aims at describing nodal and distant metastasis distribution from prostate cancer and at determining the proportion of metastatic lesions suitable for BgRT.
Treatment outcomes of metastasis-directed treatment using 68Ga-PSMA-PET/CT for oligometastatic or oligorecurrent prostate cancer: Turkish Society for Radiation Oncology group study (TROD 09-002). [2020]Label="PURPOSE" NlmCategory="OBJECTIVE">The aim of this study was to evaluate the outcomes of 68Ga prostate-specific membrane antigen (68Ga-PSMA) positron-emission tomography (PET)/CT-based metastasis-directed treatment (MDT) for oligometastatic prostate cancer (PC).