68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)

Inclusion Criteria:

- Male patients, 18 years of age or older.

- Signed and dated written informed consent by the patient prior to any study-specific
procedures.

- Histologically confirmed adenocarcinoma of the prostate.

1. Biochemical recurrence: defined as prostate specific antigen (PSA) level of ≥ 0.2
ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation
therapy with corresponding CT/MRI or bone scan revealing absence of local
recurrence or metastatic lesions.

OR

2. Metastatic disease: defined as both, castration-sensitive or castration-resistant
mPCa (presence of at least one metastatic lymph-node, visceral metastasis and/or
bone metastasis).

3. At least 2 weeks must have elapsed between last anti-cancer treatment
administration and the administration of the imaging product, 68Ga-PSMA-R2.

- Prior major surgery must be at least 12 weeks prior to study entry.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life
expectancy ≥ 6 months.

- Adequate bone marrow reserve and organ function as demonstrated by complete blood
count, and biochemistry in blood and urine at Screening:

- Hemoglobin (Hb): > 8.0 g/dL

- Platelet count of > 50.000/mm3

- Serum creatinine < 1.5 upper limit normal (ULN) or estimated glomerular filtration
rate (eGFR) > 50 mL/min based upon The Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) equation [34].

- For male patients with partners of childbearing potential, agreement to use barrier
contraceptive method (condom) and to continue its use for 28 days after IP
administration.

Exclusion Criteria:

- Pathological finding consistent with small cell, neuroendocrine carcinoma of the
prostate or any other histologies different than adenocarcinoma.

- Administered a radioisotope ≤ 10 physical half-lives prior to the day of PET/CT.

- Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or
need of indwelling/condom catheters.

- Uncontrolled pain or incompatibility that results in patient's lack of compliance with
imaging procedures

- Other known co-existing malignancies except non-melanoma skin cancer unless
definitively treated and proven no evidence of recurrence for at least 5 years.

- Patient with known incompatibility to CT scans.

- Any evidence of severe or uncontrolled systemic or psychiatric diseases, including
uncontrolled hypertension and active bleeding diatheses, which in the Investigator's
opinion makes it undesirable for the patient to participate in the trial or which
would jeopardize compliance with the protocol, or active infection including human
immunodeficiency virus (HIV) and untreated hepatitis B, hepatitis C. Screening for
chronic conditions is not required.

- Patients who have received any investigational agent within the last 28 days are
excluded from participation in this trial.

- Any acute toxicity due to prior chemotherapy and/or radiotherapy that has not resolved
according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers
Enrolled in Preventive Vaccine Clinical Trials.

- Known allergy, hypersensitivity, or intolerance to the investigational product or its
excipients.

- Patient unlikely to comply with study procedures, restrictions and requirements and
judged by the Investigator to be unsuitable for study participation.