Clinical trial · Interventional
Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer
Focal Radiation Therapy (FRaT) Trial in Patients With Low/Intermediate-Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study did not open
Summary
Brief summary (as posted)
This phase II trial studies how well focal radiation therapy with stereotactic body radiation therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or surrounding normal organs and ultimately reduce side effects while maintaining disease control.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Dose Rate Brachytherapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (SBRT)
- description
- Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm II (HDR brachytherapy)
- description
- Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: High-Dose Rate Brachytherapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy and with the following low/intermediate-risk features: * cT1c - T2b * PSA =\< 15 * \< 50% cores positive * Gleason score (GS) =\< 7 (3+4 and 4+3 included) * Multiparametric magnetic resonance imaging (MRI) (mp-MRI) confirmed lesion(s) with only one lobe involvement of the prostate * Unilateral disease on systematic biopsy * No distant or locally advanced disease on standard staging exams as indicated * Bone scan and abdominopelvic computed tomography (CT)/MRI OR * Prostate specific membrane antigen (PSMA) positron emission tomography (PET) * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment Exclusion Criteria: * Gleason score \>= 8 * Gross extracapsular extension * Seminal vesicle invasion * Radiographic nodal or distant metastatic disease * Androgen deprivation therapy within 90 days of enrollment * Lesion(s) comprising \> 40% of total prostate volume * Lesion \< 0.5 cm from urethra * Prior radical prostatectomy * Prior radiotherapy to the pelvis
References
Publications (0)
Data not yet available