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| ID | Type | Description | Link |
|---|---|---|---|
| CCR 3923 | Other Identifier | Royal Marsden NHS Foundation Trust |
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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.
Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 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
Study interventions
This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Stereotactic body radiotherapy (SBRT) to the whole prostate (36.25 Gy in 5 fractions) with a focal boost (47.5 Gy in 5 fractions) to the MRI-defined dominant tumour nodule. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute genitourinary(GU) toxicity | RTOG scale acute GU toxicity will be measured at baseline, end of treatment, then 2,4 and 12 weeks post treatment. The maximal toxicity during follow up is the primary outcome measure. | Maximal recorded toxicity within the acute toxicity period (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute gastrointestinal (GI) toxicity | RTOG scale | Within 12 weeks of treatment completion |
| Late GI and GU toxicity | RTOG scale | From 12 weeks until study completion |
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Inclusion Criteria:
Prostate cancer patients with any of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas J van As, FRCR | Contact | 02078118336 | ||
| Daniel R Henderson, FRCR | Contact | 02078118469 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden NHS Foundation trust | Recruiting | London | SW3 6JJ | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D | IPSS, IIEF-5 and EQ5-D | Baseline, 12 weeks, 12 months and 6 monthly to 5 years |
| Biochemical relapse-free survival | PSA will be measured 3-6 monthly during study | Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D008919 | Investigative Techniques |