Clinical trial · Interventional
Radiation Therapy in Treating Patients With Prostate Cancer
A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk 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)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
Conditions
Conditions (4)
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 |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 36.25 Gy IMRT | Radiation | — | UNRESOLVED |
| 51.6 Gy IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5 Fractions
- description
- 36.25 Gy IMRT in 5 fractions over two and a half weeks
- interventionNames
- Radiation: 36.25 Gy IMRT
- type
- EXPERIMENTAL
- label
- 12 Fractions
- description
- 51.6 Gy IMRT in 12 fractions over two and a half weeks
- interventionNames
- Radiation: 51.6 Gy IMRT
Primary outcomes (2)
- measure
- Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points
- timeFrame
- Baseline and one year from the end of protocol treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization
* History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization
* Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization
* Prostate-specific antigen (PSA) \< 10 ng/mL within 60 days prior to registration;
* PSA should not be obtained within 10 days after prostate biopsy
* No evidence of distant metastases
* No regional lymph node involvement
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
* No 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 of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
* No severe, active co-morbidity, 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
* Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
* Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition
* HIV testing is not required for entry into this protocol
* Protocol-specific requirements may also exclude immuno-compromised patients
PRIOR CONCURRENT THERAPY:
* No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) for prostate cancer
* No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy)
* No finasteride within 30 days prior to registration
* Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride
* No dutasteride within 90 days prior to registration
* PSA should not be obtained prior to 90 days after stopping dutasteride
* No prior or concurrent cytotoxic chemotherapy for prostate cancer
* Patients on Coumadin or other blood-thinning agents are eligible for this study
* No concurrent 3D-conformal radiation therapyReferences
Publications (0)
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