Clinical trial · Interventional
Short Course Radiotherapy for Localized Prostate Cancer
Phase I/II Study of Short-course Hypofractionated Once-weekly Radiation Therapy (SHORT) for Localized Prostate Cancer
- 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)
Hypofractionated external beam radiotherapy has been clinically used for localized prostate cancer in view of the low estimated alpha/beta ratio of prostate cancer cells. Moderate fraction sizes of \<4Gy per fraction has been investigated in several phase II/III studies and has been found to be well tolerated with comparable biochemical control in comparison with standard fractionated dose-escalated regimens. Fraction sizes of \> 4 Gy has also been investigated in single center studies. However, its toxicity and disease control outcomes is less well known. In this Phase I/II single arm study the investigators aim to treat non-metastatic prostate cancer with stageT1-T4N0M0 and Prostate Specific Antigen (PSA) \<60 ng/ml to a regimen of 35Gy in 5 fractions delivered once a week with a view to determine acute toxicity, biochemical control with PSA and late toxicity.
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 |
|---|---|---|---|
| Adenocarcinoma of Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Short-course Hypofractionated Once-weekly Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short-course Radiation Therapy
- description
- Short-course Hypofractionated Once-weekly Radiation Therapy: 35Gy in 5 fractions delivered once a week.
- interventionNames
- Radiation: Short-course Hypofractionated Once-weekly Radiation Therapy
Primary outcomes (1)
- measure
- Incidence of Acute Gastrointestinal and Genitourinary toxicity as assessed by National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
- timeFrame
- Day 29
- description
- To determine the rates of acute gastrointestinal and genitourinary toxicity according to NCI CTCAE v4.0.
Secondary outcomes (5)
- measure
- Biochemical control (with measurement of Prostate Specific Antigen measured in ng/ml)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma. * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material. * Clinical stage T1-T4N0M0 (AJCC 7th edition). Staging demands a multiparametric MRI of the pelvis a CT or MRI of the abdomen for T3/T4 tumors or PSA \>10 a whole body bone scan for T3/T4 tumors or PSA \>10 * PSA \< 60 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy. * WHO performance status 0-1 * Age ≥ 18 * Patient must sign study specific informed consent prior to accrual. 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. * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Previous pelvic irradiation in any form. * Previous hormonal therapy of more than 180 days duration prior to registration. * Previous or concurrent cytotoxic chemotherapy for prostate cancer * Severe, active comorbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.) * Renal insufficiency with a creatinine clearance of \<30ml/min
References
Publications (0)
Data not yet available