Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer (PLUTO)

Sunnybrook Health Sciences Centre

Status: Active, not recruiting

Conditions: Radical Prostatectomy; SBRT

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04067570

PLUTO

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SBRT post operative

Experimental group

Description:

Stereotactic Body Radiotherapy (SBRT) 30 Gy in 5 fractions, once weekly to prostate bed * / - 25 Gy in 5 fractions, once weekly simultaneously to pelvic lymph nodes * / - 6-24 months of androgen deprivation therapy (ADT)

Treatment:

Radiation: SBRT