Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies
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- STATUS
- Recruiting
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- End date
- Feb 25, 2028
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- participants needed
- 190
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- sponsor
- National Cancer Institute (NCI)
Summary
- Background
-
- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes
them to die. Radiation can be effective, but some tumors may be harder to treat with
radiation or even with surgery. This happens to a small number of men who have either
radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not
know if the tumor has recurred only in the prostate or has spread to another area. Also, men
whose prostate cancer has recurred only after radiation may have different treatment options.
This study will use improved imaging studies to better understand why some men do not respond
as well to initial radiation treatments.
- Objectives
- To use detailed imaging studies to look at the results of local radiation therapy for
prostate cancer.
- Eligibility
- Men at least 18 years of age who are scheduled to have radiation for prostate cancer.
- Men at least 18 years of age whose prostate cancer has returned after earlier
treatments.
- Design
- All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study.
- All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected.
- Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors.
- Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment.
- After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.
- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes
them to die. Radiation can be effective, but some tumors may be harder to treat with
radiation or even with surgery. This happens to a small number of men who have either
radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not
know if the tumor has recurred only in the prostate or has spread to another area. Also, men
whose prostate cancer has recurred only after radiation may have different treatment options.
This study will use improved imaging studies to better understand why some men do not respond
as well to initial radiation treatments.
Description
- Background
Radiation therapy is a commonly used therapy for prostate cancers. The majority of men with prostate cancer will be cured by therapy; however a subset, typically men with bulky or higher risk disease will develop PSA failure after definitive radiotherapy.
Currently, men with a rising PSA after radiotherapy may receive hormonal therapy or may undergo further evaluation for local failure.
It is not known how many men with rising PSA after radiotherapy may have a local failure and would benefit from a salvage local therapy. With the availability of a growing number of local salvage options, accurately defining the presence and characteristics of local failure is critical.
- Objective
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies
- Eligibility
Patients with no local therapy for prostate cancer:
Age greater than or equal to 18 years
Histologically confirmed adenocarcinoma of the prostate
Intermediate or high risk prostate cancer (clinical stage greater than or equal to T2b, Gleason score 7 or higher, or PSA greater than10, extracapsular extension or seminal vesicle invasion on MRI).
Patient will be treated with radiotherapy for prostate cancer.
ECOG performance status less than or equal to 2
Patients with biochemical relapse after radiotherapy for prostate cancer:
Evidence of prostate cancer recurrence (palpable abnormality after radiotherapy, radiographic evidence of local failure, biochemical relapse)
ECOG performance status less than or equal to 2
Age greater than or equal to 18 years
Histologically confirmed adenocarcinoma of the prostate
- Design
Patients with untreated prostate cancer:
Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, liver transaminases, PSA, PT/PTT), and imaging studies (as appropriate to staging).
Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research)
Patients will receive radiotherapy at NIH or at an outside facility.
Patients will return for follow up at 3 month intervals for the first 2 years and then every six months for 5 years for PSA measurement.
Patients will undergo a multiparametric MR at 6 months after therapy. No biopsy is obtained unless patients meet the definition of treatment failure. This study would allow future correlation with early changes that may predict for eventual outcome.
Patients with a rising PSA that meet the criteria for biochemical failure by the Phoenix definition will undergo repeat multiparametric prostate MRI with biopsy of suspicious lesions (diagnostic and research).
Patients with recurrent prostate cancer:
Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, Liver transaminases, PSA, PT/PTT), and imaging studies.
Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research)
120 patients with untreated prostate cancer and 100 patients with biochemical recurrence after radiotherapy will be accrued to this study.
Details
| Condition | Prostatic Neoplasms, Prostate Cancer |
|---|---|
| Clinical Study Identifier | NCT01834001 |
| Sponsor | National Cancer Institute (NCI) |
| Last Modified on | 28 October 2022 |
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Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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