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

Prostate Cancer Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02560181
• Other study ID #: clinicaltrials_hchu_180-2014
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

Intervention

Radiation:
• HDR brachytherapy
Whole gland salvage

Locations

Country	Name	City	State
Canada	Odette Cancer Centre, Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute GI toxicities	Acute GI toxicities using NCI CTCAE v4.0	3 mths post brachytherapy
Primary	Acute GU toxicities	Acute GU toxicities utilizing NCI CTCAE v4.0	3 moths post brachytherapy
Secondary	Acute GU symptoms	Acute GU symptoms American Urological Association Symptom Index Score (IPSS)	5 years
Secondary	Late GU symptoms	Late GU symptoms American Urological Association Symptom Index Score (IPSS)	5 years
Secondary	Late GI toxicities	Late GI toxicities using NCI CTCAE v.4.0	5 years
Secondary	Late GU toxicities	Late GU Toxicities using NCI CTCAE v.4.0	5 years
Secondary	Biochemical disease free survival	PSA	5 years
Secondary	Quality of Life (QoL)	QoL measured using Expanded Prostate Cancer Index Composite (EPIC)	5 years