Using imaging to assess prostate cancer response to radiation therapy

Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies

This study is testing advanced imaging techniques to see how well radiation therapy works for men with prostate cancer and if it can help identify those who might need more treatment.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: radiation
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT01834001 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the local response of prostate cancer to radiation therapy using advanced imaging techniques. It focuses on men who are either scheduled for radiation treatment or have experienced a recurrence of prostate cancer after previous treatment. The study will utilize multiparametric MRI and standard biopsies to determine the rate of local recurrence in patients, helping to identify those who may benefit from additional local therapies. By understanding the characteristics of local failure, the study seeks to improve treatment options for patients with prostate cancer.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with intermediate or high-risk prostate cancer who are scheduled to receive radiation therapy.

Not a fit: Patients with low-risk prostate cancer or those who have already undergone local therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification of patients who may benefit from salvage therapies after radiation treatment for prostate cancer.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for assessing treatment responses in prostate cancer, suggesting this approach may be effective.

Eligibility criteria

* INCLUSION CRITERIA: men with untreated prostate cancer.

  1. Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.
  2. Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).
  3. No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.
  4. Age \>18 years.
  5. ECOG performance status \<2 (Karnofsky \>60%).
  6. Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.
  7. Ability of subject to understand and the willingness to sign a written informed consent document.

INCLUSION CRITERIA: for men with presumed prostate cancer relapse

1. Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI
2. Age greater than or equal to 18 years.
3. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
4. Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.
5. Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)
6. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

1. Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).
2. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.
3. Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm\^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.
4. Subject s weight exceeding MRI or radiation treatment table tolerance.
5. Patients with active urinary tract infections.
6. Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.
7. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.
8. Hepatitis B or Hepatitis C active infection.
9. HIV-positive patients are ineligible because HIV is known to increase radiation toxicity and may result in under-dosing or alterations in the treatment plan that would alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV positive patients when indicated.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Deborah E Citrin, M.D. — National Cancer Institute (NCI)
• Study coordinator: Theresa C Cooley Zgela, R.N.

Conditions Prostatic Neoplasms; Prostate Cancer; Radiation; Biochemical Failure; Natural History