The Effect of ADT on PSMA-PET.

Prostate Cancer Clinical Trial

— ADTPSMA  

Official title:

The Effect of Androgen Deprivation Therapy on Prostate Specific Membrane Antigen (PSMA) in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03313726
• Other study ID #: T83/2017
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2017
• Last updated: October 13, 2017
• Start date: September 20, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2017
• Source: Turku University Hospital
• Contact: Jukka Kemppainen, MD, PhD
• Phone: +358-2-3130196
• Email: jukka.kemppainen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ADT.

Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is done before ADT and at maximum SUV defined by the phase A.

Description:

Positron emission tomography has been commonly and successfully used, in combination with CT and MRI devices, in the staging of intermediate or high risk prostate cancer. Proper staging is essential to guide the treatment options, which usually are radical prostatectomy or radiotherapy in localized prostate cancer or hormonal treatment in patients with metastasized disease, patients with hormonal relapse after radical radiotherapy or as an adjuvant treatment together with radiotherapy.

The use of PET imaging increases the sensitivity in the evaluation of lymph node involvement, as almost 80% of metastatic lymph nodes in prostate cancer are smaller than the threshold size usually measured with CT or MRI.

Nowadays new specific receptor targeted PET tracers in prostate cancer imaging has been introduced. One of the most used is 68Ga-PSMA that evaluates the expression of prostate-specific membrane antigen. This tracer has been rapidly taken into account for its better sensitivity and specificity in prostate cancer staging compared to the lipid metabolism tracers, like 11C/18F labeled fluorocholine or 11C-acetate.

In the recent literature it has been demonstrated for the first time on humans that PSMA expression, imaged with 68Ga-PSMA-11-PET, has increased in a patient with metastatic prostate cancer after androgen deprivation therapy (ADT).

These findings suggest that the use of hormonal therapy can affect the expression of PSMA and our hypothesis is that ADT therapy could increase the sensitivity of 68Ga-PSMA PET to detect nodal or distant metastasis in patients with prostate cancer. This prospective study consists in two phases. In phase A, 5 patients with newly diagnosed high risk prostate cancer with PSMA-positive nodal or distant metastasis screened by 68Ga-PSMA-11 PET/MRI, are given androgen deprivation therapy (ADT) with GNRH antagonist. After ADT therapy initiation, 68Ga-PSMA-11 PET/MRI is repeated at 7, 14 and 30 days to determine the highest PSMA expression based on SUVmax measurement.

In phase B, 20 high risk prostate cancer patients determined to undergo radical prostatectomy are screened with 68Ga-PSMA-11 PET/MRI, and then given GNRH antagonist therapy. 68Ga-PSMA-11 PET/MRI is repeated at the time of maximum PSMA expression based on phase A results. The patients then undergo radical prostatectomy and lymphadenectomy and imaging findings are matched with histological data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: 40 to 85 years old

• Language spoken: Finnish

• Diagnosis: Histologically confirmed adenocarcinoma of prostate

• Adequate histological sampling consisting of at least 3 biopsy samples from each lobe

• No previous surgical, radiation or endocrine treatment for prostate carcinoma

• Clinical stage: T1c-T4N0-2M0-1 (arm, A); T1c-T3NxMx (arm, B)

• Serum creatinine = 1,5 x ULN

• Patient agrees to undergo surgery (arm, B)

• Mental status: Patients must be able to understand the meaning of the study

• Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

• Infections: Patient must not have an uncontrolled serious infection

• contraindications for MRI (cardiac pacemaker, intracranial clips etc)

• Prior usage of 5-ARI medication in past 12 months

• Patient preference for active surveillance as a method of prostate cancer management

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• GnRH antagonist
Administration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max.
• GnRH antagonist
Administration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GnRh-antagonist, A	Maximum SUV in PSMA-PET	0, 7, 14 and 28 days after ADT initiation
Primary	GnRh-antagonist, B	Sensitivity and specificity of pre and post ADT 68Ga-PSMA-11 PET/MRI and standard clinical MRI using histology as a reference	0 and 7, 14 or 28 days after ADT initiation according to phase A
Secondary	GnRh-antagonist, A	Testosterone level (nmol/l)	0, 7, 14 and 28 days after ADT initiation
Secondary	GnRh-antagonist, A	PSA level (ug/l)	0, 7, 14 and 28 days after ADT initiation
Secondary	GnRh-antagonist, B	Testosterone level (nmol/l)	56 and 112 days after ADT initiation
Secondary	GnRh-antagonist, B	EPIC-questionnaire total and hormonal score	56 and 112 days after ADT initiation