Description:
Background:
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).
Objective:
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.
Eligibility:
Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no
evidence of distant metastatic disease
Design:
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.
Participantes will continue to have routine visits until two years after treatment is
completed....
Title
- Brief Title: Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
- Official Title: Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Clinical Trial IDs
- ORG STUDY ID:
170153
- SECONDARY ID:
17-C-0153
- NCT ID:
NCT03253744
Conditions
- Prostate Cancer
- Prosatatic Neoplasm
Interventions
Drug | Synonyms | Arms |
---|
18F-DCFPyL | | 1/Tumor Irradiation |
Purpose
Background:
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).
Objective:
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.
Eligibility:
Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no
evidence of distant metastatic disease
Design:
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.
Participantes will continue to have routine visits until two years after treatment is
completed....
Detailed Description
Background:
- 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 re-irradiation may potentially
increase the efficacy of re-irradiation.
Objectives:
-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.
Eligibility:
- 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%).
Design:
- 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.
Trial Arms
Name | Type | Description | Interventions |
---|
1/Tumor Irradiation | Experimental | SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy | |
2/Prostate and Tumor Irradiation | Experimental | 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 | |
Eligibility Criteria
- INCLUSION CRITERIA:
- Patients must have histologically confirmed locally recurrent adenocarcinoma of the
prostate after prior radiation (EBRT or brachytherapy).
- PSA failure after definitive radiation as defined by the Phoenix criteria (PSA
elevation at least 2 ng/dL above post-radiotherapy nadir)
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to
60%).
- Ability of subject to understand and the willingness to sign a written informed
consent document.
EXCLUSION CRITERIA:
- Patients who are receiving any other investigational agents.
- PSA greater than or equal to 20 ng/dL if no prior DCFPyL scan obtained (If PSA > 20
and DCFPyL obtained within 3 months prior to enrollment shows no evidence of
metastatic disease, subjects may be included in the study)
- Biochemical recurrence within one year of completion of radiotherapy
- Need for chronic anticoagulation therapy (chronic low dose aspirin is not an
exclusion)
- Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
- Inflammatory bowel disease
- Active Lupus or Active scleroderma
- Patients with distant metastatic disease (prostate adjacent adenopathy is not an
exclusion)
- Prior prostatectomy
- Subjects with any coexisting medical or psychiatric condition that is likely to
interfere with study procedures and/or results.
- Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
- Other medical conditions deemed by the Principal Investigator (or associates) to make
the subject unsafe or ineligible for protocol procedures
- Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within
the imaging gantry
- Serum creatinine > 2 times the upper limit of normal
- Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert s
syndrome, a total bilirubin > 3.0.
- Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal
- Patients with positive Human Immunodeficiency Virus (HIV) status and currently
requiring treatment with agents known to sensitize to irradiation, such as protease
inhibitors, will be excluded
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum tolerated dose |
Time Frame: | 3 weeks post-treatment |
Safety Issue: | |
Description: | Define the MTD of image-guided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after prior radiotherapy. |
Secondary Outcome Measures
Measure: | Sensitivity and specifity of 18F-DCFPyl imaging as compared to biopsy in detecting locally recurrent prostate cancer |
Time Frame: | 6 months after radiation |
Safety Issue: | |
Description: | Evaluate 18F-DCFPyL imaging as a method to detect locally recurrent prostate cancer after radiation. The sensitivity and specificity of DCF-PyL for detecting locally recurrent prostate cancer (at baseline) will be reported using biopsy as the gold standard. |
Measure: | Changes of quality of life scores during and after treatment |
Time Frame: | 2 years after treatment |
Safety Issue: | |
Description: | Describe the effects of focally dose escalated prostate SBRT on patient reported outcomes (SHIM, AUA Symptom Index, EPIC-26) in patients previously treated with radiotherapy. The quality of life scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for patient-specific trajectory of quality of life scores. Changes of quality of life scores during and after treatment will be calculated from the estimated linear mixed effect model. |
Measure: | biochemical progression free survival |
Time Frame: | 1 and 2 years after treamtnet |
Safety Issue: | |
Description: | Describe the rate of PSA control (bPFS, PSA < 2 ng/dL above post SBRT nadir) at 1 and 2 years after treatment with focally dose escalated SBRT for locally recurrent prostate cancer after irradiation: bPFS will be estimated by the Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model. |
Measure: | Assessment of Dose limiting toxicities |
Time Frame: | 3 weeks after end of treatment |
Safety Issue: | |
Description: | Define the dose-limiting toxicities and toxicity profile of image-guided, focally dose escalated prostate SBRT in patients previously treated with radiotherapy: DLTs will be reported descriptively. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | National Cancer Institute (NCI) |
Trial Keywords
- Image Guidance
- Dose Escalation
- Radiotherapy
- Re-irradiation
- Quality of Life
Last Updated
August 16, 2021