Clinical trial · Interventional
Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate
Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial
- 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)
Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvage radiation therapy". Currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy after prostate removal causes unpleasant side effects. A shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation. The purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. The study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.
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 |
|---|---|---|---|
| Hypofractionated therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- Hypofractionated therapy, 26 treatments at 2.5 Gy
- interventionNames
- Radiation: Hypofractionated therapy
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- Hypofractionated therapy, 20 treatments at 2.83Gy
- interventionNames
- Radiation: Hypofractionated therapy
- type
- EXPERIMENTAL
- label
- Dose Level 3
- description
- Hypofractionated therapy,15 treatments at 3.36 Gy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of prostate adenocarcinoma and * have had a prostatectomy * have detectable PSA * 18 years of age or older Exclusion Criteria: * are receiving chemotherapy or other agents intended for cancer treatment * history of rectal surgery or lower gastrointestinal bleed * history of bleeding diathesis or abnormal sensitivity to ionizing radiation * had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation
References
Publications (1)
- BACKGROUNDWages NA, Sanders JC, Smith A, Wood S, Anscher MS, Varhegyi N, Krupski TL, Harris TJ, Showalter TN. Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1254-1262. doi: 10.1016/j.ijrobp.2020.11.009. Epub 2020 Nov 21. PMID 33227441