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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04067570
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 18, 2020
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
SBRT Radical Prostatectomy Radiation: SBRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Study
Actual Study Start Date : November 7, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SBRT post operative

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)
Radiation: SBRT
Stereotactic body radiation therapy, or SBRT, is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue

Primary Outcome Measures :
  1. Acute genitourinary (GU) and gastrointestinal (GI) toxicities [ Time Frame: Through accrual completion, up to 3 years ]
    Based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcome Measures :
  1. Incidence of late GU and GI toxicities (≥6 months) [ Time Frame: Through accrual completion, up to 3 years ]
    Using CTCAE v5.0

  2. Biochemical disease-free survival (bDFS) [ Time Frame: Through study completion, up to 3 years ]
    Biochemical disease-free survival (bDFS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer- male patients only
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04067570

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Contact: Principle Investigator 416 480 4998

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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Chia-Lin (Eric) Tseng, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT04067570    
Other Study ID Numbers: PLUTO
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases