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Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04838899
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Urban Emmenegger, Sunnybrook Health Sciences Centre

Brief Summary:
There is increasing worldwide interest in exploring stereotactic ablative body radiotherapy (SABR) for treating metastases in men with prostate cancer, including for the treatment of oligoprogressive metastases. The latter applies to a situation whereby patients with widespread metastases undergoing systemic therapy present with a solitary or a few metastatic tumors that progress, while all other metastases are stable or responding. The usual practice would be to change systemic therapy at this point, but another approach is to locally ablate the "rogue" metastases and continue the same systemic therapy. SABR used in this scenario may delay the need to switch to another line of systemic therapy and improve progression-free survival while patients stay on the same systemic therapy.

Condition or disease Intervention/treatment Phase
Oligoprogressive Castration-Resistant Prostate Cancer Radiation: Stereotactic Body Radiation Therapy (SABR) Not Applicable

Detailed Description:

There is increasing worldwide interest in exploring the use of SABR for metastatic, treatment-naive prostate cancer, eg for delaying the need to start androgen deprivation therapy (ADT), and ultimately to improve patient outcome.

Another potential use of SABR for metastatic prostate cancer is in the setting of oligoprogression. In patients undergoing systemic therapy, oligoprogression describes the clinical situation where a solitary or a few metastatic tumors progress, while all other metastases are stable or responding. The usual practice would be to change systemic therapy at this point, but another approach is to locally ablate the "rogue" metastases and continue the same systemic therapy. There is limited clinical evidence for such an approach, eg in renal cell and non-small cell lung cancer.

While there is a lack of published evidence of such an approach in metastatic castration-resistant prostate cancer (mCPRC), SABR for oligoprogressive mCRPC in men undergoing abiraterone therapy may delay the need to switch to another line of systemic therapy, such as chemotherapy, and thereby to improve progression-free survival while patients stay on the same systemic therapy.

mCRPC is a unique solid tumor to study the oligoprogressive setting for several reasons. First, there still remains a limited number of proven systemic agents in the CRPC setting. Second, serum prostate specific antigen (PSA) is an excellent biomarker of prostate cancer activity, which is easy to collect and analyze to monitor treatment response and disease progression. Third, because of the low α/β value of prostate cancer, hypofractionated SABR may be a very effective and convenient way to eradicate areas of known disease.

The primary objective of this phase I study is to determine the incidence of acute and late toxicities associated with delivering SABR to all progressive metastatic sites in patients with metastatic CRPC who present with oligoprogression while on abiraterone. We also aim to obtain preliminary efficacy data of this novel approach. Patients will remain on abiraterone after SABR to measure the added progression-free survival.

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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: Stereotactic Ablative Radiotherapy for Oligoprogressive Metastatic Castration-Resistant Prostate Cancer During Abiraterone Therapy
Actual Study Start Date : July 16, 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Abiraterone

Arm Intervention/treatment
Experimental: Treatment Arm
All metastases that fulfill the definition of oligoprogression seen on conventional imaging will be treated with standard SABR dose fractionation schemes routinely used at Sunnybrook Odette Cancer Centre. The prostate (if present and not previously treated) will be treated to a dose of 35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Spine metastases will be treated to a dose of 24 Gy in 2-3 fractions or 30-40 Gy in 5 fractions. Involved lymphadenopathy will be treated to a dose of 30-40 Gy in 5 fractions. Similarly, brain, lung, liver, and adrenal metastases will be treated with standard Sunnybrook SABR doses. Patients will remain on abiraterone during and after SABR treatments.
Radiation: Stereotactic Body Radiation Therapy (SABR)
SABR to oligoprogressive metastases while continuing abiraterone therapy




Primary Outcome Measures :
  1. SABR-related toxicities [ Time Frame: 12 months ]
    Incidence of acute and late toxicities (including radiation induced bone fractures) after comprehensive SABR to all progressing metastases seen on conventional imaging.

  2. Progression-free survival [ Time Frame: 24 months ]
    Time to clinical (i.e., radiological and/or symptomatic) progression following SABR.


Secondary Outcome Measures :
  1. Biochemical progression-free survival [ Time Frame: 24 months ]
    Time to PSA progression

  2. Time to changing systemic therapy [ Time Frame: 24 months ]
    Time to starting subsequent line of systemic therapy

  3. Radiographic local control rate of the SABR-treated areas [ Time Frame: 24 months ]
    Monitoring lack of progression of oligoprogressive sites of disease

  4. Radiographic distant progression-free survival [ Time Frame: 24 months ]
    Time to metastatic progression outside of SABR-treated areas

  5. Overall survival [ Time Frame: 36 months ]
    Time to death from prostate cancer or other cause

  6. Quality of Life (QoL) assessment [ Time Frame: 12 months ]
    QoL assessment using EORTC QLQ-C30 at baseline, plus 1, 3, 6, 9 and 12 months after SABR



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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:

  • ECOG performance status 0-1.
  • Histologic confirmation of prostate adenocarcinoma.
  • Documentation of metastatic, castration-resistant prostate cancer.
  • Patient being treated with abiraterone.
  • Evidence of oligoprogression (according to RECIST [V1.1] and/or Prostate Cancer Working Group criteria [PCWG3], as applicable), applying any of the following: (i) ≤ 5 metastatic lesions progressing on conventional imaging (≤ 3 progressing metastases in any one organ system) while all other metastases are controlled or responding; (ii) PSA progression only, but in the setting of oligometastases (≤ 5 metastatic lesions seen on imaging, with ≤ 3 metastases in any one organ system); in this setting, all metastases will be irradiated.
  • All metastases of interest amenable to SABR.

Exclusion Criteria:

  • Patients presenting with unequivocal clinical progression, defined as one of the following: (i) cancer pain requiring the initiation of opioid therapy; (ii) immediate need for cytotoxic chemotherapy as per treating physician's discretion; or (iii) deterioration of performance status to grade ≥ 3 according to ECOG.
  • Evidence of spinal cord compression.
  • 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): NCT04838899


Contacts
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Contact: Urban Emmenegger, MD +416-480-4928 urban.emmenegger@sunnybrook.ca

Locations
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Canada, Ontario
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Urban Emmenegger, MD    +1-416-480-4928    urban.emmenegger@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Urban Emmenegger, Medical Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04838899    
Other Study ID Numbers: #351
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases