Clinical trial · Interventional
Hypofractionated Radiation Therapy in Prostate Cancer
Stereotactic Body Radiation Therapy for cT1c - cT3a Prostate Cancer With a Low Risk of Nodal Metastases (≤ 20%, Roach Index): a Novalis Circle Phase II Prospective Randomized Trial
NCT01764646CI-TRIAL-00045157unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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: It is not yet known whether extreme hypofractionation is equally safe and effective than standard radiation therapy in treating prostate cancer. PURPOSE: This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Disease | — | UNRESOLVED | — |
| Malignant Neoplasm of Prostate | Malignant Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image guided radiation therapy | Radiation | — | UNRESOLVED |
| Intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
| Volumetric modulated arc therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 9 days
- description
- Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) once a week over 28 days
- interventionNames
- Radiation: Intensity modulated radiation therapy
- Radiation: Volumetric modulated arc therapy
- Radiation: Image guided radiation therapy
- type
- EXPERIMENTAL
- label
- 28 days
- description
- Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) other 9 days.
- interventionNames
- Radiation: Intensity modulated radiation therapy
- Radiation: Volumetric modulated arc therapy
- Radiation: Image guided radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age: \>18 * WHO performance status ≤ 2 * Any patient where prophylactic lymph node irradiation is not required, i.e. risk of nodal microscopic involvement ≤ 20% (according to Roach et al (25): "N+ (in %) = (Gleason score - 6) x 10 + 2/3 PSA at diagnosis)" * T-stage: cT1-cT3a. * Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy. * Combined hormonal treatment (Neoadjuvant-concomitant androgen deprivation, AD, for 6 months) is mandatory if two or more of the following tumour characteristics are present: ≥cT2c, Gleason 4+3, PSA \>10 ng/ml, perineural invasion, and/or \>1/3 of positive biopsies. RT shall be delivered between 2 and 3 months (+/- 1 week) after starting AD and according to the following chronologic sequence: 1. Neoadjuvant AD for 2 months (30 days of bicalutamide 50mg qd, and a 3-month slow-releasing LH-RH analog to be started 15 days after initiating bicalutamide). 2. Randomization at the end of the neoadjuvant AD period (2 months after starting AD). 3. Planning RT (to be started within 1 month after randomization (i.e., between the 2nd and 3th month after initiating AD) * Concomitant and adjuvant HT for 4 more months (a second 3-month slow-releasing LH-RH analog injection). Exclusion Criteria: * Inability to obtain a written informed consent * Patient preference to be treated with one rather than the other treatment arm. * WHO performance status \> 2 * cT3b,cT4 * Gleason score ≥8 * Clinical N+ on metastases work-up or N+ risk \>20% (Roach algorithm) * Severe urinary obstructive symptoms (IPSS symptom index \>19) * Previous TURP less than 8 weeks before radiotherapy * Previous prostate surgery other than TURP
References
Publications (0)
Data not yet available
No reference posted for this study.