Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

Korábbi kezelés

• Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.
• Prior treatment with chemotherapy for prostate cancer or bilateral orchiectomy. Note: prior chemotherapy for a different type of cancer is allowed if the patient has been continuously disease-free for > 3 years.
• Bilateral hip prosthesis, treated earlier with definitive prostate radiotherapy, who have evidence of local disease recurrence within the prostate and no option for salvage treatment with brachytherapy or surgery.
• Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.

Életkor

• Age < 18.
• Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years.

Egyéb

• ECOG Performance Status ≥3.
• PSA ≥ 20 ng/ml.
• Intracranial or intrathecal metastasis.
• Spinal cord compression, or spinal intramedullary metastasis.

• Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.
• Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.
  • Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI and PSMA-PET, will be accepted for study enrollment.
• All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.
• Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:
  • After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;
  • After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.