Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate ca

NCT04236752 | Unknown DMC

• 1 other identifier: SPARE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

HIGH RISK PROSTATE CANCER

Outcome Measures

Primary Outcomes (1)

• Acute GI and GU toxicities

  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).

  Baseline (start of treatment) to 6 weeks post completion of Radiation treatment

Secondary Outcomes (4)

• Late GI and GU RTOG toxicities

  6 months post start of treatment to end of 5 year follow up post completion of treatment

• Quality of Life outcome- EPIC

  Baseline ( start of treatment) to end of 5 year follow up post completion of treatment

• Biochemical disease-free survival

  Baseline ( start of treatment) to end of 5 year follow up post completion of treatment

• Quality of Life outcome- EQ5D

  Baseline to end of 5 year follow up post completion of treatment

Other Outcomes (1)

• Quality of Life outcome- PORPUS-U

  Baseline ( start of treatment) to end of 5 year follow up post completion of treatment

Study Arms (1)

Single arm radiotherapy

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Body Radiation (SBRT)

Interventions

Stereotactic Ablative Body Radiation (SBRT) RADIATION

Single arm radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Prostate Cancer Canada: collaborator

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontairo, M4N 3M5, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: January 22, 2020
• Study Start: September 29, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)