Recurrent Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, mpMRI, salvage HDR brachytherapy
Brief summary
A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.
Detailed description
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and if PSA is rising during follow-up, PSMA PET will be ordered when clinically indicated..
Interventions
RADIATIONHDR partial prostate brachytherapy
temporary radioactive implant
Sponsors
British Columbia Cancer Agency
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
High Dose Rate brachytherapy
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>45 and Life expectancy \>10 years * Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w * \> 3 year interval since EBRT or LDR Brachytherapy * No late toxicity from prior EBRT ≥ grade 2 * PSA \> nadir + 2 ng/ml and \< 10 ng/ml * PSA Doubling time \> 6 months * Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence). * Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general. * Negative staging of the abdomen/pelvis and bones. * Willing to provide informed consent
Exclusion criteria
* Not compliant with criteria above * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late adverse gastrointestinal or genitourinary events grade 3 or higher | 3-60 months | Common Terminology Criteria for Adverse Events (CTCAE V4.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Quality of Life | 3-60 months | Expanded Prostate Cancer Index (EPIC) |
| Late lower urinary tract symptoms | 3-60 months | International Prostate Symptom Score |
| Acute grade 3 or higher gastrointestinal or genitourinary adverse events | 0-3 months | Common Terminology Criteria for Adverse Events (CTCAE V4.0) |
| Acute Quality of Life changes | 0-3 months | Expanded Prostate Cancer Index (EPIC) |
| Acute lower urinary symptoms | 0-3 months | International Prostate Symptoms Score |
| Biochemical disease free survival | 60 months | PSA \< 0.4 ng/ml at 60 months |
| Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA. | 2 years | Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA. |
Countries
Canada
Contacts
CONTACTJuanita Crook, MD
STUDY_DIRECTORMira Keyes, MD
BCCA
Outcome results
None listed