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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer Recurrent
• Interventions: Radiation: HDR brachytherapy

• Registration Number: NCT02560181
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HDR whole gland salvage treatment	HDR brachytherapy	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

Primary Outcome Measures

Name	Time	Method
Acute GI toxicities	3 mths post brachytherapy	Acute GI toxicities using NCI CTCAE v4.0
Acute GU toxicities	3 moths post brachytherapy	Acute GU toxicities utilizing NCI CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Late GU toxicities	5 years	Late GU Toxicities using NCI CTCAE v.4.0
Acute GU symptoms	5 years	Acute GU symptoms American Urological Association Symptom Index Score (IPSS)
Late GU symptoms	5 years	Late GU symptoms American Urological Association Symptom Index Score (IPSS)
Quality of Life (QoL)	5 years	QoL measured using Expanded Prostate Cancer Index Composite (EPIC)
Biochemical disease free survival	5 years	PSA
Late GI toxicities	5 years	Late GI toxicities using NCI CTCAE v.4.0

Trial Locations

Locations (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada