Clinical trial · Interventional
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score
NCT05100472CI-TRIAL-00096963active not recruitingPhase 2ClinicalTrials.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)
The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.
Conditions
Conditions (1)
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy (ADT) | Biological | — | UNRESOLVED |
| Brachytherapy | Radiation | — | UNRESOLVED |
| Hypofractionated pelvic External beam radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hormone Therapy and Radiation
- description
- Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
- interventionNames
- Biological: Androgen deprivation therapy (ADT)
- Radiation: Brachytherapy
- Radiation: Hypofractionated pelvic External beam radiation
Primary outcomes (1)
- measure
- Distant metastatic disease-free (DMF) rate
- timeFrame
- 3 years
- description
- Time to distant metastases will be estimated from the date of enrollment until distant metastases
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically-proven diagnosis of prostate adenocarcinoma * Clinical stage T3-4 or Gleason score 8-10 or PSA \>20 ng/ml °If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or \>90% probability of having T3-T4 disease determined by the reading radiologist. * Decipher genomic score ≤0.6 * Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) * Age ≥18 * KPS ≥70 or ECOG 0-2 * Estimated life expectancy \>5 years * Baseline prostate volume ≤90 cc * Baseline IPSS ≤20 * No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice * Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration Exclusion Criteria: * Regional lymph node or metastatic disease * Prior pelvic radiation * Prior prostate surgery (including TURP or cryosurgery) * Prior history of inflammatory bowel disease * Unable to undergo anesthesia or brachytherapy * Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
References
Publications (0)
Data not yet available
No reference posted for this study.