Clinical trial NCT04067570: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer
Official title: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: SBRT
Radical Prostatectomy
Keywords: Prostate cancer
Radiation
Ultrahypofractionated Radiotherapy
PSA Rise
SBRT
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radical prostatectomy is a common treatment for localized prostate cancer. More than 30% of men who undergo surgery will subsequently develop recurrence, particularly in patients with adverse features where the risk may be even higher. Recurrence typically manifests as a rise in serum-level of prostate-specific antigen (PSA), referred to as biochemical recurrence. Post-operative radiotherapy is a potentially curative option for many patients, as shown in multiple prior randomized studies. A standard course of post-operative radiation requires 6 to 6 and half weeks of treatment, 5 days a week; however, new high-precision radiation techniques with image guidance, termed stereotactic body radiotherapy (SBRT), can deliver an equivalent or higher dose of treatment in 5 visits. Our group, amongst others, have demonstrated in previous studies, that the new 5-treatment technique was safe, convenient and effective in patients with intact prostates. Currently, limited data exists on this approach after prostatectomy. This study will be one of the first to assess the side effect profile and efficacy of SBRT in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.


Eligibility criteria: Inclusion Criteria:

* • Histologically confirmed diagnosis of adenocarcinoma of the prostate

  * Completed written informed consent
  * Able and willing to complete self report questionnaires
  * Pathologic stage T3 or T4 (without any gross residual disease), NX-0, M0, and/or +ve surgical margins, and/or a rising PSA post-radical prostatectomy on at least 2 consecutive measurements

Exclusion Criteria:

* • Gross residual disease

  * Histological or radiological node +ve (N1) or distant metastases (M1)
  * Prior pelvic radiotherapy
  * Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
  * Hip prosthesis

Primary outcomes:
measure: Acute genitourinary (GU) and gastrointestinal (GI) toxicities
timeFrame: Through accrual completion, up to 3 years
Secondary outcomes:
measure: Incidence of late GU and GI toxicities (≥6 months)
timeFrame: Through accrual completion, up to 3 years
measure: Biochemical disease-free survival (bDFS)
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: