Prostate Cancer
Conditions
Keywords
Prostate Cancer, VMAT, Dominant Intraprostatic Lesion, Intensity modulated radiotherapy
Brief summary
The aim of this study was to determine the efficacy and safety of the implementation of a program of image-guided focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).
Detailed description
The aim of this study was to determine the efficacy and safety of the implementation of a program of image-guided focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).
Interventions
RADIATIONIGRT/VMAT focal therapy boost to DIL
Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy
Sponsors
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male \> 18 years old with histologic diagnostic of prostate adenocarcinoma * Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition) * PSA (prostate-specific antigen) \< 100 ng/ml * Gleason score 6-10 * Life expectancy \> 5 years * Patients who accept the radiotherapy treatment * Patients provided written informed consent before participating in the trial
Exclusion criteria
* Transurethral resection of the prostate or prior prostate surgery * Previous pelvic radiotherapy * Urethral stenosis with or without prior dilations * IPSS\>15 * Rectal diverticuli or rectal vascular malformations * Metastatic disease * Severe psychiatric or medical conditions that could hamper both treatment and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biochemical Failure at 5 Years | 5 years | Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml) |
| Local Control | 6 and 9 months following radiotherapy | An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy. |
| Acute and Late Rectal and Urinary Complications | 5 years | Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Free of Biochemical Progression | 5 years | Biochemical disease-free survival according to the Phoenix definition (PSA \>2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact. |
| Verification of Safety Margins | 5 years | Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula |
| Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score | 5 years | Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains |
| Disease-free Survival (DFS) | 5 years | Survival free of any event including biochemical failure, local failure, distant metastasis or death |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IGRT/VMAT Focal Therapy Boost to DIL Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria
IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | IGRT/VMAT Focal Therapy Boost to DIL | — |
|---|---|---|
| Age, Continuous | 72.0 years | — |
| Clinical T stage T2: Tumor confinent whitin prostate | 23 Participants | — |
| Clinical T stage T3: Tumor extends through the prostate capsule | 7 Participants | — |
| Gleason group (ISUP 2014/WHO 2016) Group 1: | 6 Participants | — |
| Gleason group (ISUP 2014/WHO 2016) Group 2 | 13 Participants | — |
| Gleason group (ISUP 2014/WHO 2016) Group 3 | 7 Participants | — |
| Gleason group (ISUP 2014/WHO 2016) Group 4 | 2 Participants | — |
| Gleason group (ISUP 2014/WHO 2016) Group 5 | 2 Participants | — |
| Pre-treatment PSA (ng/ml) | 8.5 ng/ml | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Spain | 30 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 27 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Acute and Late Rectal and Urinary Complications
Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).
Time frame: 5 years
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute urinary | Grade 2 | 6 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute urinary | Grade >2 | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late rectal | Grade 2 | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late rectal | Grade >2 | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute rectal | Grade 0 | 28 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute rectal | Grade 1 | 2 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute rectal | Grade 2 | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute rectal | Grade >2 | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute urinary | Grade 0 | 11 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Acute urinary | Grade 1 | 13 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late rectal | Grade 0 | 27 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late rectal | Grade 1 | 3 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late urinary | Grade 0 | 27 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late urinary | Grade 1 | 3 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late urinary | Grade 2 | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Acute and Late Rectal and Urinary Complications | Late urinary | Grade >2 | 0 Participants |
Primary
Local Control
An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.
Time frame: 6 and 9 months following radiotherapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IGRT/VMAT Focal Therapy Boost to DIL | Local Control | Yes | 30 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Local Control | No | 0 Participants |
Primary
Number of Participants With Biochemical Failure at 5 Years
Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
Time frame: 5 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IGRT/VMAT Focal Therapy Boost to DIL | Number of Participants With Biochemical Failure at 5 Years | Yes | 0 Participants |
| IGRT/VMAT Focal Therapy Boost to DIL | Number of Participants With Biochemical Failure at 5 Years | No | 30 Participants |
Secondary
Disease-free Survival (DFS)
Survival free of any event including biochemical failure, local failure, distant metastasis or death
Time frame: 5 years
Secondary
Number of Participants Free of Biochemical Progression
Biochemical disease-free survival according to the Phoenix definition (PSA \>2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.
Time frame: 5 years
Population: Localized prostate cancer (PCa) of intermediate and high risk
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IGRT/VMAT Focal Therapy Boost to DIL | Number of Participants Free of Biochemical Progression | 30 Participants |
Secondary
Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score
Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains
Time frame: 5 years
Population: No clinical data were collected for this outcome.
Secondary
Verification of Safety Margins
Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula
Time frame: 5 years