Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT04838899|
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Oligoprogressive Castration-Resistant Prostate Cancer||Radiation: Stereotactic Body Radiation Therapy (SABR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Progression-free survival [ Time Frame: 24 months ]Time to clinical (i.e., radiological and/or symptomatic) progression following SABR.
- Biochemical progression-free survival [ Time Frame: 24 months ]Time to PSA progression
- Time to changing systemic therapy [ Time Frame: 24 months ]Time to starting subsequent line of systemic therapy
- Radiographic local control rate of the SABR-treated areas [ Time Frame: 24 months ]Monitoring lack of progression of oligoprogressive sites of disease
- Radiographic distant progression-free survival [ Time Frame: 24 months ]Time to metastatic progression outside of SABR-treated areas
- Overall survival [ Time Frame: 36 months ]Time to death from prostate cancer or other cause
- 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
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
|Contact: Urban Emmenegger, MDfirstname.lastname@example.org|
|Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Urban Emmenegger, MD +1-416-480-4928 email@example.com|