Clinical trial · Interventional
High-Dose Brachytherapy in Treating Patients With Prostate Cancer
A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
NCT02346253CI-TRIAL-00116630completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.
Conditions
Conditions (5)
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 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Degarelix | Drug | Degarelix | ALIAS |
| Goserelin Acetate | Drug | Goserelin | ALIAS |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Triptorelin Pamoate | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
- description
- Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
- interventionNames
- Radiation: Internal Radiation Therapy
- Drug: Bicalutamide
- Drug: Leuprolide Acetate
- Drug: Goserelin Acetate
- Drug: Triptorelin Pamoate
- Drug: Degarelix
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
- timeFrame
- Within 6 months of HDR completion
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Documented pathologic confirmation of prostate adenocarcinoma * Clinical T-classification T1-3 * PSA \< 150 ng/mL * Gleason score 6-10 * Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for clinical classification of T3 (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are \<1 cm in short axis diameter. \[56\] * No evidence of bone metastases (M0) on bone scan, only for PSA \>20 ng/mLor Gleason ≥8, (NaF PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if plain films and/or MRI are negative for definite metastases. * American Urological Association Symptom Index (AUA SI) =\< 20 Exclusion Criteria: * Clinical T4 disease * PSA \>= 150 ng/mL * AUA SI \> 20 * History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer * Previous chemotherapy for any malignancy, if given within three years of registration * History of rectal surgery * History of rectal fistula * History of inflammatory bowel disease * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last six months * Transmural myocardial infarction within the last six months
References
Publications (0)
Data not yet available
No reference posted for this study.