Clinical trial · Interventional
Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate ca
Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate Cancer (SPARE)
NCT04236752CI-TRIAL-00042944SPAREunknownN/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)
HDR brachytherapy in conjunction with pelvic SABR in high tier intermediate and high risk prostate cancer patients can provide a safe and effective means of radiotherapy dose escalation. Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIGH RISK PROSTATE CANCER | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Ablative Body Radiation (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm radiotherapy
- description
- HDR Brachytherapy Boost of 15Gy to the prostate followed by Stereotactic Ablative Body Radiation (SBRT) 25 Gy in 5 fractions, once weekly to prostate, SVs and pelvic lymph nodes + 6-18 months of ADT
- interventionNames
- Radiation: Stereotactic Ablative Body Radiation (SBRT)
Primary outcomes (1)
- measure
- Acute GI and GU toxicities
- timeFrame
- Baseline (start of treatment) to 6 weeks post completion of Radiation treatment
- description
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v3.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks. This will be calculated using the F distribution method (exact confidence limits).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Informed consent obtained
* Men \>18 years
* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High tier intermediate risk defined as :
Clinical stage T1-T2c AND PSA 10-20ng/ml AND {PSA\>10ng/ml AND (T2b-2c Or Gleason 7)} OR Gleason 4+3
-High-risk prostate cancer, defined as at least one of: Clinical stage T3, OR Gl 8-10, OR PSA \> 20 ng/mL
Inclusion Criteria:
* Prior pelvic radiotherapy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Large prostate (\>50cm3) on imaging
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7 nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive regional or distant metastatic disease on staging investigations.References
Publications (0)
Data not yet available
No reference posted for this study.