To evaluate efficacy and tolerability of deferred androgen deprivation therapy +/- upfront CRyOtherapy in men with localised radiation recurrent Prostate cancer (RRPC)

Phase 3

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN72677390
• Lead Sponsor: HS Greater Glasgow & Clyde (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26482768 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-26
• Study Completion: 2020-06-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 540

Inclusion Criteria

1. Histologically confirmed relapsed prostate cancer following previous treatment with radiation therapy (either external beam or brachytherapy) for either organ confined or non-metastatic locally advanced prostate cancer, namely T1-3aN0M0 disease
2. Life expectancy of at least 5 years
3. Clinical/radiological T1c-T3a
4. Prostrate specific antigen (PSA) level = 20 ng/ml
5.. Aged 18 years or over
6. Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) = 0 or 1 or 2
7. Ability to provide informed consent
8. Adequate haematological function as defined by haemoglobin (Hb) = 100g/L; platelets = 100 x 109/L; neutrophils =1.5 x109/L
9. Adequate biochemical function as defined by bilirubin = 1.5 upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 2.5 x ULN, alkaline phosphatase = 2.5 x ULN and adequate renal function defined as either serum creatinine = 1.5 x ULN OR calculated/measured creatinine clearance = 60mls/min (as defined by Cockcroft and Gault formula); Target Gender: Male ; Lower Age Limit 18 years

Exclusion Criteria

1. Lymph node >10mm short axis on magnetic resonance imaging (MRI) abdomen and pelvis
2. Previous transurethral resection of prostate gland with evidence of a significant defect (>10mm in width) on transrectal ultrasound scan
3. Significant lower urinary tract symptoms, including bladder outflow obstructive symptoms
4. History of abdomino-perineal resection of rectum.
5. Known coagulation disorder
6. Complex perianal fistula
7. Previous combined external beam radiotherapy and brachytherapy to the prostate
8. Significant symptoms/toxicity related to the rectum following radiotherapy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or above
9. Failed androgen deprivation therapy as second line therapy for radiation recurrent prostate cancer
10. Prior cryotherapy to the prostate
11. Any evidence of severe or uncontrolled systemic conditions (e.g. severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
12. Other prior malignancy with estimated =30% chance of relapse within 5 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distant Metastasis Free Survival (DMFS); Timepoint(s): DMFS assessed annually by MRI and bone scan

Secondary Outcome Measures

Name	Time	Method
<br> 1. Acute and late side effects of cryotherapy; Timepoint(s): Meausred using NCI CTCAE; Efficacy; Timepoint(s): PSA 3 monthly in year 1, annually thereafter<br> 2. Prostate biopsy at 6 months post cryotherapy; Functional Status; Timepoint(s): validated questionnaires at 3, 6, 12 months and annually thereafter<br>