[18F] Dihyro-testosterone(FDHT) PET/CT- A novel Imaging technique in Patients with Porgressive Prostate Cancer

Phase 1

• Conditions: Progressive Prostate cancer; MedDRA version: 18.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005684-32-GB
• Lead Sponsor: The Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

1 Patients with histologically confirmed prostate cancer (Male =18 years old, no upper limit)

2 Progressive disease manifest by either:
2.1 Imaging modalities:
Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or
MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease.
Or
2.2. Biochemical progression:
A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.

3 Visible lesions by CT, bone imaging or MRI, consistent with disease.

4 Informed consent: able and willing to give written informed consent and to comply with the study protocol procedures.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Previous anaphylactic reaction to 18F-FDHT.

2. Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin <2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase >2.5 x ULN.

3. Renal: Creatinine > 1.5 x ULN or creatinine clearance <60mL/min.

Study & Design

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