Stereotactic Radiotherapy for Oligometastatic Prostate Cancer (CROP)
Comprehensive Stereotactic Radiotherapy for Oligometastatic Prostate Cancer: A Phase I/II Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Odette Cancer Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Stereotactic radiotherapy
Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease
Lasso di tempo: cumulative incidence at 2 years
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common terminology criteria for adverse events (CTCAE) version 4.0
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cumulative incidence at 2 years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Quality of Life (EORTC QLQ-C30)
Lasso di tempo: proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
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proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
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Time to development of castrate resistant prostate cancer
Lasso di tempo: through study completion, an average of 2 years
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through study completion, an average of 2 years
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Radiographic local control of irradiated tumours
Lasso di tempo: actuarial rate at 2 years
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actuarial rate at 2 years
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Radiographic "distant" control rate
Lasso di tempo: actuarial rate at 2 years
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actuarial rate at 2 years
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Overall survival
Lasso di tempo: through study completion, an average of 4 years
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through study completion, an average of 4 years
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Patrick Cheung, M.D., Toronto Sunnybrook Regional Cancer Centre
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CROP
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