A study to investigate whether a combined Positron emission tomography (PET) and computerised tomography (CT) scan which utilises a tracer called Prostate Specific Membrane Antigen (PSMA) - a substance expressed by prostate cancer cells - can be used to better identify locally recurrent prostate cancer in men with a rising Prostate Specific Antigen (PSA) following radical prostatectomy. The study will then measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.

Phase 2

Active, not recruiting

• Conditions: Recurrent prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12615001183572
• Lead Sponsor: Icon Cancer Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-03
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

Phase I (PSMA PET/CT)
- Males age 18 years or older.
- Patients who have undergone radical prostatectomy for histologically confirmed clinical stage T1- T3 invasive prostate adenocarcinoma.
- Post-operative PSA 0.1-2.5ng/ml.
- No contraindications to undergoing 68Ga-PSMA-ligand PET/CT (including severe claustrophobia).
- ECOG Status 0-2
- Able to undergo intensity modulated radiotherapy.
- Patients or their legal representatives must have the ability to read, understand and provide written informed consent.
- Able to participate in the stipulated follow-up (either telephone follow-up or on-site visits acceptable, but one follow-up annually should be in person).
- Participants capable of child-bearing are using adequate contraception.

Phase II (radiotherapy)
- No evidence of metastatic disease on PSMA-PET
or
- localized recurrence on PSMA-PET

Inclusion criteria for Calypso beacons
- Body habitus enabling Calypso (Registered Trademark) localisation and tracking (as per Calypso (Registered Trademark) Determining a Patient’s Localisation Designation & Orientation before implantation).
- Able to undergo Calypso (Registered Trademark) beacon insertion.

Exclusion Criteria

- Prostate cancer with significant sarcomatoid, ductal, spindle cell or neuroendocrine small cell components.
- Evidence of secondary disease outside the prostate bed.
- Previous radiotherapy treatment to the pelvis.
- Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer.
- Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer.
- Inflammatory bowel disease (active) such as Crohn’s disease and ulcerative colitis.
- Haemorrhagic cystitis.
- Known hypersensitivity to 68Ga, PSMA or any of the excipients of 68Ga-PSMA.
- Insufficient renal function (eGFR < 30 mL/min/1.73 m2).
- Androgen Deprivation Therapy within 6 months prior to enrolment.
- Unable to lie flat and/or still during PET-CT.
- Patients unable or unwilling to comply with study requirements.
- Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.

Exclusion criteria for Calypso beacon insertion:
- Any urogenital anatomic abnormality that would interfere with the ability to access the Calypso (Registered Trademark) beacon insertion site.
- Pacemaker or implanted defibrillator.
- Presence of hip prosthesis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified