Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02145494
Status:
UNKNOWN
Last Update Posted:
2014-05-23
First Post:
2013-06-04
Brief Title:
The SPARC Trial Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
Stereotactic Prostate Augmented Radiotherapy With Cyberknife
Status:
UNKNOWN
Status Verified Date:
2014-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC
Brief Summary:
Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control This trial will assess whether this technique delivered in 5 treatments can be delivered without increasing side effects
Detailed Description:
Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 3625 Gy in 5 fractions to the whole prostate gland
Primary end-point Acute toxicity Radiation Therapy Oncology Group RTOG International prostate symptom score IPSS
Secondary end-points Prostate specific antigen PSA nadir and 2-year biochemical control Late toxicity IPSS RTOG International index of erectile function IIEF-5 Quality of life EQ5D scale
Inclusion criteria
Prostate cancer patients with any of the following
PSA20
Gleason grade 43 or higher
Stage T3a
Exclusion criteria
Nodal or metastatic disease
PSA40
Stage T3b or higher
Study interventions
This is a phase II study which will recruit 20 patients A dose of 3625 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 475 Gy in 5 fractions or to the highest dose possible within dose constraints The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist
Primary end-point Acute toxicity Radiation Therapy Oncology Group RTOG International prostate symptom score IPSS
Secondary end-points Prostate specific antigen PSA nadir and 2-year biochemical control Late toxicity IPSS RTOG International index of erectile function IIEF-5 Quality of life EQ5D scale
Inclusion criteria
Prostate cancer patients with any of the following
PSA20
Gleason grade 43 or higher
Stage T3a
Exclusion criteria
Nodal or metastatic disease
PSA40
Stage T3b or higher
Study interventions
This is a phase II study which will recruit 20 patients A dose of 3625 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 475 Gy in 5 fractions or to the highest dose possible within dose constraints The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCR 3923 | OTHER | Royal Marsden NHS Foundation Trust | None |