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

NCT02560181 | Active Not Recruiting DMC

• 1 other identifier: clinicaltrials_hchu_180-2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Recurrent

Keywords

recurrent prostate cancer, HDR whole gland salvage

Outcome Measures

Primary Outcomes (2)

• Acute GI toxicities

  Acute GI toxicities using NCI CTCAE v4.0

  3 mths post brachytherapy

• Acute GU toxicities

  Acute GU toxicities utilizing NCI CTCAE v4.0

  3 moths post brachytherapy

Secondary Outcomes (6)

• Acute GU symptoms

  5 years

• Late GU symptoms

  5 years

• Late GI toxicities

  5 years

• Late GU toxicities

  5 years

• Biochemical disease free survival

  5 years

Study Arms (1)

HDR whole gland salvage treatment

OTHER

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

Interventions

HDR brachytherapy RADIATION

Whole gland salvage

HDR whole gland salvage treatment

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hans Chung, MD

  Odette Cancer Centre, Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 25, 2015
• Study Start: August 1, 2014
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CA (1)