Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02560181
Collaborator
(none)
30
1
1
121
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Study Details

Study Description

Brief Summary

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease (cryotherapy), and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate.

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

Detailed Description

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease (cryotherapy), and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate. Reports of the efficacy and toxicities of whole gland salvage HDR brachytherapy for local recurrence after external beam radiation therapy are limited to single-institution studies with small sample sizes. Given that our institution has the highest volume of prostate brachytherapy cases in Ontario and that we receive a significant number of referrals from other cancer centres for brachytherapy, this study will aim to add to the literature and help guide salvage therapy practice within our institution.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
Study Start Date :
Aug 1, 2014
Anticipated Primary Completion Date :
Aug 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: HDR whole gland salvage treatment

Locally recurrent prostate cancer Whole gland HDR brachytherapy administered Whole gland dose=10.5Gy x 2 fractions delivered one week apart GTV dose=13.5Gy x 2 fractions delivered one week apart

Radiation: HDR brachytherapy
Whole gland salvage

Outcome Measures

Primary Outcome Measures

  1. Acute GI toxicities [3 mths post brachytherapy]

    Acute GI toxicities using NCI CTCAE v4.0

  2. Acute GU toxicities [3 moths post brachytherapy]

    Acute GU toxicities utilizing NCI CTCAE v4.0

Secondary Outcome Measures

  1. Acute GU symptoms [5 years]

    Acute GU symptoms American Urological Association Symptom Index Score (IPSS)

  2. Late GU symptoms [5 years]

    Late GU symptoms American Urological Association Symptom Index Score (IPSS)

  3. Late GI toxicities [5 years]

    Late GI toxicities using NCI CTCAE v.4.0

  4. Late GU toxicities [5 years]

    Late GU Toxicities using NCI CTCAE v.4.0

  5. Biochemical disease free survival [5 years]

    PSA

  6. Quality of Life (QoL) [5 years]

    QoL measured using Expanded Prostate Cancer Index Composite (EPIC)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Biopsy confirmed locally recurrent prostate adenocarcinoma > 30mths after completion of XRT by stereotactic transperineal biopsy

  • Staging T2-weighted, DWI- and DCE- MRI that demonstrates recurrence confined to prostate, and correlates with stereotactic transperineal biopsy

  • Previous external beam radiotherapy for prostate cancer with standard/conventional fractionation (1.8-2.0 Gy per fraction), or moderate hypofractionation (2.4-3.4 Gy per fraction).

  • Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases

  • IPSS < 15

  • Baseline (post XRT) serum PSA < 10ng/mL

  • Prostate volume as measured by TRUS < 50cc

  • ECOG performance status 0-1

Exclusion Criteria:
  • Disease adjacent to the urethra as visible on MRI

  • Any of the following prior therapies; TURP, radionuclide prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU, bilateral orchiectomy, chemotherapy for prostatic carcinoma

  • Evidence of castrate resistance (defined as PSA > 3ng/mL while testosterone is < 1.7nmol/L) Patients could have been on combined androgen blockade with initial XRT but are excluded if this was started due to PSA progression

Contacts and Locations

Locations

Site City State Country Postal Code
1 Odette Cancer Centre, Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Hans Chung, MD, Odette Cancer Centre, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Hans Chung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02560181
Other Study ID Numbers:
  • clinicaltrials_hchu_180-2014
First Posted:
Sep 25, 2015
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Keywords provided by Dr. Hans Chung, Radiation Oncologist, Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022