Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

Must have received: androgen deprivation therapy (LHRH agonist, bilateral orchiectomy) — ongoing

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

Cannot have received: androgen receptor axis-targeted therapy (abiraterone, enzalutamide, apalutamide)

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

Cannot have received: androgen receptor inhibitor (bicalutamide, flutamide, nilutamide, cyproterone acetate)

Treatment with estrogens or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 4 weeks of enrollment (Day 1 visit)

Cannot have received: androgen synthesis inhibitor (abiraterone acetate, enzalutamide, apalutamide, TAK-700, TAK-683, TAK-448)

Prior use of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, enzalutamide, Apalutamide, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS 641988) on clinical trials

Cannot have received: androgen receptor inhibitor (BMS 641988)

Prior use of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, enzalutamide, Apalutamide, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS 641988) on clinical trials

Cannot have received: systemic biologic therapy

Exception: approved bone targeted agents and GnRH-analogue therapy allowed

Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumour activity within 4 weeks of enrollment (Day 1 visit)

Cannot have received: cytotoxic chemotherapy

Exception: adjuvant setting post radical therapy is allowed

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

Cannot have received: radiation therapy

Exception: radiation exposure prior to the development of the metastases is permitted as long as the radiation exposure was not intended for the 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...)

Cannot have received: radiation therapy

Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit)

Cannot have received: radiation or radionuclide therapy

Radiation or radionuclide therapy for treatment of metastasis

Cannot have received: investigational agent

Use of an investigational agent within 4 weeks of enrollment (Day 1 visit)

Cannot have received: herbal products with hormonal anti-prostate cancer activity and/or known to decrease PSA levels (saw palmetto)

Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit)

Cannot have received: systemic corticosteroid

Exception: ≤ 10 mg prednisone equivalent per day allowed

Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit)