Clinical trial · Interventional
Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer
Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized 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): PI no longer with the institution
Summary
Brief summary (as posted)
The aim of this study is to determine the maximum tolerated dose of hypo-fractionated radiation therapy and the toxicity of the treatment program. Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT). Dose escalation will be as follows: There will be 3 cohorts consisting of 3 patients each.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy
- description
- Radiation Therapy
- interventionNames
- Radiation: Radiation
Primary outcomes (1)
- measure
- the maximum tolerated dose of HRT
- timeFrame
- 30 weeks
- description
- After accrual of dose level I, all patients will be observed for a minimum of two weeks after completion of radiation treatments, for assessment of toxicity, before the dose can be escalated for the next cohort. After dose level II, patients will be observed for 6 months before enrolling patients on dose level III.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * Clinical stage T1-2c (AJCC 6th edition) * Gleason \<6 and PSA \<10 ng/mL * Gleason =7 and/or PSA 10-20 ng/mL provided \<34% of core biopsies are positive for carcinoma * PSA \< 20 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy. * Zubrod performance status 0-1 * Age ≥ 18 * Patient must sign study specific informed consent prior to randomization. Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible) * Evidence of distant metastases * Regional lymph node involvement * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Prior androgen deprivation therapy (ADT) * Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Previous or concurrent cytotoxic chemotherapy for prostate cancer
References
Publications (0)
Data not yet available