Prostate Cancer Recurrent
Conditions
Keywords
recurrent prostate cancer, HDR whole gland salvage
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.
Interventions
RADIATIONHDR brachytherapy
Whole gland salvage
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Late GI toxicities | 5 years | Late GI toxicities using NCI CTCAE v.4.0 |
| 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) |
| Quality of Life (QoL) | 5 years | QoL measured using Expanded Prostate Cancer Index Composite (EPIC) |
| Biochemical disease free survival | 5 years | PSA |
| Late GU symptoms | 5 years | Late GU symptoms American Urological Association Symptom Index Score (IPSS) |
Countries
Canada
Outcome results
None listed