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Active, Not Recruiting

NCT Number: NCT02560181

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDR Brachytherapy

Radiation

Whole gland salvage

Primary outcomes

  1. Acute GI toxicities

    Time frame: 3 mths post brachytherapy

    Acute GI toxicities using NCI CTCAE v4.0

  2. Acute GU toxicities

    Time frame: 3 moths post brachytherapy

    Acute GU toxicities utilizing NCI CTCAE v4.0

Secondary outcomes

  1. Acute GU symptoms

    Time frame: 5 years

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

  2. Late GU symptoms

    Time frame: 5 years

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

  3. Late GI toxicities

    Time frame: 5 years

    Late GI toxicities using NCI CTCAE v.4.0

  4. Late GU toxicities

    Time frame: 5 years

    Late GU Toxicities using NCI CTCAE v.4.0

  5. Biochemical disease free survival

    Time frame: 5 years

    PSA

  6. Quality of Life (QoL)

    Time frame: 5 years

    QoL measured using Expanded Prostate Cancer Index Composite (EPIC)

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2015
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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