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Active, not recruiting

NCT Number: NCT01583920

Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. 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, 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. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

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 > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
  • Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
  • Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
  • American Urological Association Symptom Index Score (ie. IPSS) < 15
  • Baseline (post-XRT) serum PSA < 10 ng/mL
  • Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
  • ECOG performance status 0-1

Exclusion criteria

  • Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
  • Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.

Treatment and study plan

focal salvage HDR prostate brachytherapy

Radiation

Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.

Primary outcomes

  1. Incidence of acute urinary and rectal toxicities

    Time frame: Acute period (<6 months)

    Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Secondary outcomes

  1. Incidence of late urinary and rectal toxicities

    Time frame: Late period (>6 months)

    Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  2. Biochemical (ie. prostate specific antigen) disease free survival

    Time frame: 5 years

  3. Quality of Life (QoL)

    Time frame: 5 years

    Expanded Prostate Cancer Index Composite (EPIC)

  4. Acute and late urinary toxicities

    Time frame: 5 years

    American Urological Association Symptom Index Score (i.e. IPSS)

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Association of Radiation Oncology

Registry information

Official study title

Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Important dates

Study start
2012
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2012
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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