5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
Oligometastatic Prostate CancerWe will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
null
Conditions de participation
-
Sexe:
MALE -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Able to provide informed consent
* European Cooperative Oncology Group performance status 0 to 2
* Medically fit for all protocol treatment and follow-up
* Histologically confirmed adenocarcinoma of the prostate
* Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases
* No prior therapy for prostate cancer apart from androgen deprivation
* Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization
* If used, anti-androgens must have started within 26 weeks of randomization
* Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA)
* Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen \& pelvis or MRI abdomen and pelvis, and Bone scan)
* Planned for long-term androgen deprivation therapy
Exclusion Criteria:
* High metastatic burden defined as 5 or more bone metastases or visceral metastases
* Abnormal liver function
* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
* Medically unfit for anesthesia
* International Prostate Symptom Score (IPSS) greater than 20
* Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)
* Prostate volume greater than 60cc after maximal cytoreduction
* Pubic arch interference
* Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy
Lieu de l'étude
Vancouver Cancer Center
Vancouver Cancer CenterVancouver, British Columbia
Canada
Contactez l'équipe d'étude
Fraser Valley Cancer Center
Fraser Valley Cancer CenterSurrey, British Columbia
Canada
Contactez l'équipe d'étude
Vancouver Island Cancer Center
Vancouver Island Cancer CenterVictoria, British Columbia
Canada
Contactez l'équipe d'étude
British Columbia Cancer Agency Center for the Southern Interior
British Columbia Cancer Agency Center for the Southern InteriorKelowna, British Columbia
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- British Columbia Cancer Agency
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT04610372