Completed

NCT Number: NCT03617588

68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer

This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Guy's and St Thomas' Hospital (PIC), London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group A: Adenocarcinoma of the prostate gland suitable for radical Tx.

Adenocarcinoma of Prostate
Gleason score 4+3 and above, or PSA > 20 ng/mL or clinical stage >T2C.
Suitable for surgical tx
No Hormone Therapy in last 3 months

Group B: PCa and a diagnosis of BCR, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent).

Original diagnosis of PCa, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on:

Post RP: two consecutive rises in PSA and final PSA >0.lng/ml OR Post RP: three consecutive rises in PSA. This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
Post RP: PSA doubling time of ~15 months OR PSA level 0.5 ng/ml.
No previous recurrences of PCa.
Consideration for radical salvage therapy.
Should not have received androgen-deprivation therapy within 3 months of screening.
No Hormone Therapy in last 3 months

Group C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent).

The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:
Increase in PSA level ~2.0 ng/ml above the nadir level after radiotherapy (RT) or brachytherapy, no previous recurrences of BCR.
The subject is being considered for radical salvage therapy.
Should not have received androgen-deprivation therapy within 3 months of screening.
No hormone therapy within the past three months.

Exclusion criteria

Group A:

Prior Tx for Prostate Tumours
Gleason < 4+3
Hip prostheses
eGFR <20

Group B:

Hormone Therapy in the last 3 months
Hip prostheses
eGFR <20

Group C:

Hormone Therapy in the last 3 months
Hip prostheses
eGFR <20

Treatment and study plan

Gallium-68 THP-PSMA

Drug

Subjects will undergo a Gallium-68 THP-PSMA scan in addition to standard of care monitoring. The results of this scan may influence the patient management plan.

Other names: THG-001

Primary outcomes

Change in Patient Management

Time frame: up to 3 months post PET/CT

The impact of 68Ga-THP-PSMA PET/CT on the management of patients with PCa was analysed by measuring the percentage of patients who had a change in management plan as a result of 68Ga-THP-PSMA PET/CT documented after scan, compared with their pre-scan management plan. A change status of 'Yes' was assigned if there was any difference in treatment options between the intended and revised management plans. A change status of 'No' was assigned if the intended and revised management plans remained identical. This endpoint was assessed in the full analysis set, but as a sensitivity analysis, was also assessed in the per protocol population in case there was a difference between the populations. As all 49 patients underwent a technically successful post-baseline scan, the full analysis set and per protocol populations were the same.

Secondary outcomes

Safety - Treatment Emergent Adverse Events

Time frame: Safety was assessed at screening, during the study and at Visit 4. AEs, regardless of relationship to study treatment, were recorded from the time of 68Ga-THP-PSMA administration until 30 days after the administration of 68Ga-THP-PSMA.

Safety was assessed by means of physical examination, vital signs, cardiovascular profile, performance status, laboratory evaluations (haematology, biochemistry, urinalysis and prostate-specific antigen), recording of concurrent illness/therapy and AEs. No dose limiting toxicity was defined in this study.

Sponsors and collaborators

Lead sponsor

Theragnostics Ltd

Industry

Registry information

Official study title

A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients With High Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment (PRONOUNCED Study)

Acronym: PRONOUNCED

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Aug 6, 2018
Registry last updated: Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed