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Stereotactic Radiotherapy for Oligometastatic Prostate Cancer (CROP)

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ClinicalTrials.gov Identifier: NCT02563691
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Patrick Cheung, Sunnybrook Health Sciences Centre

Brief Summary:
This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Radiation: stereotactic radiotherapy Not Applicable

Detailed Description:

Patients will receive androgen deprivation therapy (ADT) for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken, where ADT will not be restarted until the prostate specific antigen (PSA) reaches a minimum of 10-15 ng/mL. Lupron 30 mg IM will be delivered every 4 months when on ADT.

The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. It is very likely that nodal metastases will shrink significantly (often completely) with ADT. In this scenario, the involved nodal regions will be treated to a more modest dose of 25 Gy in 5 fractions (roughly equivalent to a dose of 46 Gy in 23 fractions assuming an α/β value of 1.4). Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established stereotactic radiotherapy (SRT) policies at Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.

During any "off" period of ADT (before the PSA rises above 10-15 ng/mL), comprehensive SRT can be repeated if there are new oligometastases that become visible. One month after initiation comprehensive SRT, patients will be contacted to assess for acute toxicities.

After completion of radiotherapy to all disease sites, patients will be followed every 3-4 months with PSA testing until the development of castrate resistant prostate cancer. At the same time points, late toxicity and quality of life will be collected for a minimum of 2 years. Computed tomography (CT) of the chest/abdo/pelvis +/- magnetic resonance imaging (MRI) of previously irradiated body sites and bone scan will be performed whenever the PSA reaches ≥ 10 ng/mL (prior to re-starting androgen deprivation therapy during intermittent hormone therapy approach), or at a minimum frequency of once per year.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Stereotactic Radiotherapy for Oligometastatic Prostate Cancer: A Phase I/II Study
Actual Study Start Date : November 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Stereotactic radiotherapy
Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.
Radiation: stereotactic radiotherapy

Patients will receive ADT for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken.

The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established SRT policies at the Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.

Other Name: SBRT, SABR




Primary Outcome Measures :
  1. Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease [ Time Frame: cumulative incidence at 2 years ]
    common terminology criteria for adverse events (CTCAE) version 4.0


Secondary Outcome Measures :
  1. Quality of Life (EORTC QLQ-C30) [ Time Frame: proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months ]
  2. Time to development of castrate resistant prostate cancer [ Time Frame: through study completion, an average of 2 years ]
  3. Radiographic local control of irradiated tumours [ Time Frame: actuarial rate at 2 years ]
  4. Radiographic "distant" control rate [ Time Frame: actuarial rate at 2 years ]
  5. Overall survival [ Time Frame: through study completion, an average of 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide informed consent.
  • ECOG performance status 0-1.
  • Histologic confirmation of prostate adenocarcinoma.
  • Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.
  • ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).
  • All sites of disease are amenable to stereotactic radiotherapy.

Exclusion Criteria:

  • Castrate resistant prostate cancer.
  • Evidence of spinal cord compression.
  • Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).
  • Inability to safely treat all sites of visible disease.
  • Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.

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 ClinicalTrials.gov identifier (NCT number): NCT02563691


Contacts
Contact: Andrea Deabreu 416-480-6100 ext 1058 Andrea.Deabreu@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kristina Commisso, B.Sc.    416-480-6100 ext 87741    kristina.commisso@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Patrick Cheung, M.D. Toronto Sunnybrook Regional Cancer Centre

Responsible Party: Dr. Patrick Cheung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02563691     History of Changes
Other Study ID Numbers: CROP
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases