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Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer

Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months
  • Procedures mentioned: Questionnaires, Blood draws, MRI scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Prostate specific antigen (PSA) response at 6 weeks after radiation therapy (RT), every 3 months for 24 months, every 6 months to 60 months, then every 8-12 months until 5 years."
  • "Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire; VIb."
  • "Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire."
  • "Patients also undergo blood sample collection, multiparametric (mp) magnetic resonance imaging (MRI) and optionally prostate-specific membrane antigen (PSMA) positron emission tomography (PET) throughout the study."
  • "Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests high-dose-rate brachytherapy (HDR-BT) for people age 40 or older with prostate cancer. This treatment puts radioactive material directly into or near the tumor. The study looks at whether it can control cancer in the treated area while reducing side effects.

This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older.
  • A systematic biopsy, which takes tissue samples from across the prostate, confirmed prostate adenocarcinoma within 90 days before signing up.
  • A detailed MRI scan shows one or more areas of cancer.
  • Staging scans show no cancer that has spread far away or grown extensively into nearby areas.
  • Within 60 days before joining, you can do all usual activities or have limits only with hard physical activity.

Who can't join

  • Scans show cancer in lymph nodes or distant parts of the body.
  • The cancer areas take up more than 40% of the prostate.
  • You have had radiation treatment to the pelvis.
  • Cancer outside the planned treatment area has a Gleason score above 6. This score rates how abnormal cancer cells look under a microscope.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy * Multiparametric MRI (mp-MRI) confirmed lesion(s) * No distant or locally advanced disease on standard staging exams as indicated * Bone scan and abdominopelvic computed tomography (CT)/MRI OR * PSMA PET * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment * Age ≥ 40 Exclusion Criteria: * Radiographic nodal or distant metastatic disease * Lesion(s) comprising \> 40% of total prostate volume * Prior radiotherapy to the pelvis * Gleason score \> 6 disease outside intended gross target volume (GTV)/target region(s)

Study sites (1)

CA