The Role of Therapeutic Layering of Stereotactic Body Radiotherapy on Darolutamide in the Management of Oligoprogressive Castration Resistant Prostate Cancer: a Pilot Phase II Trial

Who is this study for? Adult patients with oligoprogressive metastatic castration-resistant prostate cancer
What treatments are being studied? Darolutamide+SBRT
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;

• M0CRPC at study entry defined as follows:

‣ Ongoing androgen deprivation therapy with a LHRH agonist or bilateral orchiectomy (i.e., surgical or medical castration);

⁃ Serum testosterone level ≤ 1.7 nmol/L (50 ng/dL) at the Screening visit;

⁃ PSA progression defined by a minimum of two subsequent rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL)

⁃ PSA doubling time of 10 months or less,

⁃ M0 assessed by conventional imaging (CT/MRI + bone scan).

∙ NOTE: If darolutamide started prior to study entry, evidence of inclusion criteria 1-5 listed above prior to start of darolutamide must be submitted to determine study eligibility

• Prior cytotoxic chemotherapy for prostate cancer in adjuvant setting post radical therapy is allowed;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or Karnofsky performance status of \> 80% or higher;

• Estimated life expectancy of ≥ 6 months;

• Ability to swallow the study drug whole and comply with study.

• Patients should not have been previously exposed to other ARATs (Abiraterone, Enzalutamide, Apalutamide)

• ≤ 5 metastatic sites (on conventional imaging);

• ≤ 4 tumors within any given organ system, excluding brain (e.g. up to 4 bone metastases, or 4 lung metastases);

• All sites of disease must be amenable to SBRT with no history of the metastases being irradiated (radiation exposure prior to the development of the metastases is permitted as long as the radiation exposure was not intended for the metastases. For example, if there is prior pelvic radiation to the prostate and a subsequent iliac metastasis develops within the previously irradiated pelvic radiation field, then the iliac metastasis would be eligible per the institution policy and practice);

• In the case of a suspicious lesion in an unusual location such as lung or thoracic lymph nodes (without other abdominal lymph nodes), a confirmatory imaging or biopsy is strongly recommended;

Locations
Other Locations
Canada
Prostate Cancer Centre
RECRUITING
Calgary
Centre of Applied Urology Research
RECRUITING
Halifax
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Service d'urologie et Centre de la prostate
RECRUITING
Longueuil
Centre hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Hôpital Maisonneuve-Rosemont
RECRUITING
Montreal
Sir Mortimer JGH
RECRUITING
Montreal
L'Hôtel-Dieu de Québec (CHUQ)
RECRUITING
Québec
Hôpital Fleurimont (CHUS)
RECRUITING
Sherbrooke
Centre hospitalier affilié universitaire régional (CHAUR)
RECRUITING
Trois-rivières
Contact Information
Primary
Paola Diego
paola.diego.ccomtl@ssss.gouv.qc.ca
514-340-8222
Time Frame
Start Date: 2020-10-19
Estimated Completion Date: 2027-11
Participants
Target number of participants: 66
Treatments
Experimental: Darolutamide (BAY1841788)+ SBRT
CRPC subjects will receive LHRH agonist in combination with the new generation of hormonal therapy Darolutamide (300mg).~Subjects who progress on LHRH + Darolutamide and develop oligometastases will receive SBRT
Related Therapeutic Areas
Sponsors
Leads: Sir Mortimer B. Davis - Jewish General Hospital

This content was sourced from clinicaltrials.gov