Stereotactic Radiotherapy for Oligometastatic Prostate Cancer (CROP)
|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: NCT02563691|
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Radiation: stereotactic radiotherapy||Not Applicable|
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)|
|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|
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
- 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
- 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 ]
- Time to development of castrate resistant prostate cancer [ Time Frame: through study completion, an average of 2 years ]
- Radiographic local control of irradiated tumours [ Time Frame: actuarial rate at 2 years ]
- Radiographic "distant" control rate [ Time Frame: actuarial rate at 2 years ]
- Overall survival [ Time Frame: through study completion, an average of 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563691
|Contact: Andrea Deabreu||416-480-6100 ext 1058||Andrea.Deabreu@sunnybrook.ca|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Kristina Commisso, B.Sc. 416-480-6100 ext 87741 firstname.lastname@example.org|
|Principal Investigator:||Patrick Cheung, M.D.||Toronto Sunnybrook Regional Cancer Centre|