Radium-223 in patients with PSA progression and without clinicalmetastases following maximal local therapy: a pilot study

Phase 1

• Conditions: Patients with prostate cancer (PCa) who experience PSA progressionand who are without detectable metastases following maximal localtreatment consisting of radical prostatectomy (RP) + pelviclymphadenectomy (PLND) and external beam radiotherapy (EBRT), orwho present only with biochemical relapse after salvage lymph nodedissection. Among patients with PSA relapse, those at major risk ofmetastatic progression will be studied.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002833-70-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-01
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Subjects must meet all the following criteria to be enrolled in the study:
1. Male aged 18 years or older with histological confirmation of prostatic adenocarcinoma.
2. Ability to provide informed consent and demonstration of willingness to follow all study phases.
3. Patient has to agree to use effective birth control method during and for 6 months after discontinuation of study treatment.
4. Patient is experiencing biochemical progression according to the following definition:
a. PSA >0.2 ng/ml following maximal local treatment consisting of RP and PLND and adjuvant or salvage EBRT
b. PSA >0.2 ng/ml following maximal local therapy consisting of salvage LND in patients treated primarily by RP + PLND and adjuvant or
salvage EBRT.
5. Negative prognostic factors for metastatic progression.
a. At least 1 of the risk factors should be present according to the
following specific patient scenarios (for group at point 4a).
• Salvage EBRT group (at least one of subsequent factors)
- PSADT <12 months (postoperative PSA)
- pT =3
- pGS =8
• Adjuvant EBRT group (at least one of subsequent factors):
- pT =3 and pGS =8
- pT =3 and detectable postoperative PSA
- PSADT <12months (PSA post adjuvant EBRT)
• pN1 (at least one of subsequent factors):
- pGS =8
- pT =3
- =3 positive nodes
- Positive surgical margins
b. At least 1 of the risk factors should be present according to the
following specific patient scenarios (for group at point 4b):
• PSA=0.2 ng/ml relapse within 40 days after salvage lymph node
dissection
• Retroperitoneal lymph node positivity at salvage lymph node
dissection
6. Absence of metastatic disease at Choline PET-CT, 18F-Fluoride PETCT and whole-body MRI.
7. Adequate haematological, liver and renal function:
• Absolute neutrophil count (ANC) = 1.5 x109/l
• Platelet count = 100 x109/L
• Hemoglobin =10.0 g/dl (100 g/l; 6.2 mmol/l)
• Total bilirubin level = 1.5 x institutional upper limit of normal (ULN)
or Gilbert Syndrome without any other liver dysfunction.
• Aspartate aminotransferase (AST) = 2.5 x ULN
• Alanine aminotransferase (ALT) = 2.5 x ULN
• Creatinine = 1.5 x ULN
• Albumin > 25 g/l
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Patients should not meet any of the following criteria:
1. Previous (ADT stopped at least 6 months before screening is allowed
and serum testosterone assay should be evaluated in these patients to
exclude levels <20ng/dl. If testosterone levels have been demonstrated
as =20ng/dl after interruption of ADT, further testosterone evaluations
can be avoided) and ongoing systemic PCa therapies or other PCa
investigational treatments including also 5-alpha reductase inhibitors,
azole antifungal agents, corticoids, food supplements containing soy
isoflavones.
2. Radiotherapy to approximately >25% of bone marrow, including
hemibody radiation.
3. Bone systemic therapy.
4. Other malignancy treated within the last 3 years.
5. Have any contraindication to imaging diagnostic procedures (Choline
PET-CT,18F- Fluoride PET-CT and whole-body MRI).
6. Diagnosis of visceral and/or node and/or bone metastases at Choline
PET-CT and/or 18F- Fluoride PET-CT and/or whole-body MRI.
7. Any other serious illness or medical condition, such as but not limited to:
- Any major infection
- Cardiac failure New York Heart Association (NYHA) III or IV
- Crohn's disease or ulcerative colitis
- Bone marrow dysplasia
- Fecal incontinence
8. Medical condition or other elements that, in the investigator's opinion, could decrease the possibility to reach objectives of the study.
9. ECOG performance status =2
10. Life expectancy < 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified