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SalvageHDR: Partial Prostate Salvage High Dose Rate Brachytherapy

Sponsor
British Columbia Cancer Agency (Other)
Overall Status
Recruiting
CT.gov ID
NCT03246802
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
120
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: HDR partial prostate brachytherapy
 N/A

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 repeat mpMRI at 2 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
High Dose Rate brachytherapyHigh Dose Rate brachytherapy
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: HDR partial prostate brachytherapy

2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI

Radiation: HDR partial prostate brachytherapy
temporary radioactive implant

Outcome Measures

Primary Outcome Measures

  1. Late adverse gastrointestinal or genitourinary events grade 3 or higher [3-60 months]

    Common Terminology Criteria for Adverse Events (CTCAE V4.0)

Secondary Outcome Measures

  1. Late Quality of Life [3-60 months]

    Expanded Prostate Cancer Index (EPIC)

  2. Late lower urinary tract symptoms [3-60 months]

    International Prostate Symptom Score

  3. Acute grade 3 or higher gastrointestinal or genitourinary adverse events [0-3 months]

    Common Terminology Criteria for Adverse Events (CTCAE V4.0)

  4. Acute Quality of Life changes [0-3 months]

    Expanded Prostate Cancer Index (EPIC)

  5. Acute lower urinary symptoms [0-3 months]

    International Prostate Symptoms Score

  6. Biochemical disease free survival [60 months]

    PSA < 0.4 ng/ml at 60 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age >45 and Life expectancy >10 years

  • Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions

  • 3 year interval since EBRT

  • No late toxicity from prior EBRT > grade 2

  • Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml

  • PSA Doubling time > 6 months

  • Negative staging with CT scan of the abdomen/pelvis and bone scan

  • Able to undergo multiparametric MRI with endorectal coil

  • Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease

  • Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB)

  • Willing to provide informed consent

  • History and physical examination within 90 days of registration

  • ECOG performance status 0-1 prior to registration

  • IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second).

  • No prior trans urethral prostatic resection

  • Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)

  • No history of inflammatory bowel disease or previous rectal surgery

  • Suitable for procedure under anesthesia, spinal or general

  • INR <2.5 and platelet count >75 x 109/L

  • Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist

Exclusion Criteria:

  • Not compliant with criteria above

  • Unable to give informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 BCCA Center for the Southern Interior Kelowna British Columbia Canada V1Y 5L3

Sponsors and Collaborators

  • British Columbia Cancer Agency

Investigators

  • Study Director: Mira Keyes, MD, BCCA

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Juanita Crook, Professor of Radiation Oncology, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT03246802
Other Study ID Numbers:
  • H17-01641
First Posted:
Aug 11, 2017
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juanita Crook, Professor of Radiation Oncology, British Columbia Cancer Agency
recurrent prostate cancer
mpMRI
salvage HDR brachytherapy
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 1, 2021