Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
|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: NCT03253744|
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : March 22, 2018
Prostate cancer is the second leading cause of cancer death in U.S. men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).
To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.
Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease
Participants will be screened with blood tests, physical exam, and medical history. They may also have:
Magnetic resonance imaging (MRI) scan of the prostate..
PET/CT scan. Participants will get an injection of 18F-DCFPyL for the PET scan. They will lie very still on their back on the scanner table.
Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation.
About 2 weeks later, participants will have a radiation treatment planning CT scan.
Participants will answer questions about their urine function, bowel function, erectile function, and mood.
Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.
Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires.
Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated....
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prosatatic Neoplasm||Drug: 18F-DCFPyL Radiation: Tumor Irradiation Radiation: Prostate radiation + tumor boost irradiation||Phase 1|
National Cancer Institute (NCI) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to the side effects of available treatments such as surgery and cryoablation. Re-irradiation with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer disease control with tolerable side effects. Using image guidance to allow highly conformal focal reirradiation may potentially increase the efficacy of re-irradiation.
-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence of prostate cancer after prior radiotherapy.
- Histological confirmation of recurrent prostate cancer after prior irradiation (external beam or brachytherapy)
- No evidence of distant metastases of prostate cancer
- No prior prostatectomy
- Subject is greater than or equal to18 years old
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
This is a Phase I trial of focal dose escalation with SBRT using image and pathologic guidance. Areas in the prostate shown to have tumor on biopsy or with advanced imaging studies will be treated with highly conformal SBRT over a period of two to three weeks. Treatment will be guided and gated by fiducials implanted in the prostate. Patients will be treated to escalating doses based on tolerability of the treatment. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. Up to 52 patients will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy|
|Anticipated Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||June 20, 2019|
|Estimated Study Completion Date :||December 20, 2019|
Experimental: Tumor Irradiation
SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy
Subjects will receive 18F-DCFPyL at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 10 mCi.Radiation: Tumor Irradiation
SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy
Experimental: Prostate and Tumor Irradiation
SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
Subjects will receive 18F-DCFPyL at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 10 mCi.Radiation: Prostate radiation + tumor boost irradiation
SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
- Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]Define the MTD of imageguided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after priorradiotherapy.
- Assessment of Dose limiting toxicities [ Time Frame: 3 weeks after end of treatment ]
- biochemical progression free survival [ Time Frame: 1 and 2 years after treamtnet ]
- Changes of quality of life scores during and after treatment [ Time Frame: 2 years after treatment ]
- Sensitivity and specifity of 18FDCFPyl imaging as compared tobiopsy in detecting locally recurrent prostate cancer [ Time Frame: 6 months after radiation ]
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): NCT03253744
|Contact: Theresa Cooley-Zgela, R.N.||(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:||Deborah E Citrin, M.D.||National Cancer Institute (NCI)|