Phase 2
Completed N=347
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
Source: ClinicalTrials.gov NCT00214097 ↗Enrolled (actual)
347
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants Who Experience Grade 3 or Higher Acute Toxicities — 1; 1; 0 Participants
Summary
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience Grade 3 or Higher Acute Toxicities |
1; 1; 0 | — |
| PRIMARY Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up |
14; 26; 29 | — |
| SECONDARY Biochemical Progression-free Survival Based on PSA Surveillance |
91.5; 92.7; 94.1 | — |
| SECONDARY Fox Chase Bowel Survey at Baseline and 3 Years |
90.0; 88.0; 86.2; 86.3; 87.7; 85.4 | — |
| SECONDARY Fox Chase Bladder Survey at Baseline and 3 Years |
84.2; 84.7; 82.7; 79.5; 82.5; 81.1 | — |
| SECONDARY International Index of Erectile Function (IIEF) Score at Baseline and 3 Years |
15.6; 17.6; 15.1; 10.4; 13.6; 9.6 | — |
| SECONDARY Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years |
9.7; 9.4; 9.5; 9.5; 9.8; 9.5 | — |
Eligibility Criteria
Inclusion Criteria
Histologically proven adenocarcinoma of the prostate.
- Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
- Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
- Gleason score ≤ 7
- No evidence of distant metastasis
- Age 18+
- Informed consent signed in accordance with institutional protocol
- Pretreatment evaluations must be completed as specified in Section 7.0.
- ECOG performance status 0-1
- No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
- No previous or concurrent cytotoxic chemotherapy
- No radical surgery or cryosurgery for prostate cancer
- The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
- The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
- No current use of anticoagulation therapy, other than aspirin.
Data sourced from ClinicalTrials.gov (NCT00214097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.