Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Low and intermediate risk patients, for whom surgery is considered, will be randomised to prostatectomy vs prostate SBRT delivered with 36.25 Gy in 5 fractions.

Low and intermediate risk patients, for whom surgery is not considered or who refuse surgery, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 78 Gy in 39 fractions or 62 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.

Intermediate and high risk patients, indicated for 6 months ADT, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 60 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.

Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.

Prostatectomy

Conventional fractionation delivered to a dose of:

(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions

Conventionally Fractionated Prostate Radiotherapy

Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.

Prostate SBRT

Nicholas van As, MD

Peter Ostler, MD

Alison Tree, MD

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Multicentre, international phase 3 randomised controlled study comprising three parallel randomisations with a common experimental arm.

Prostate Advances in Comparative Evidence

International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer

Biochemical progression is defined as: Phoenix definition

Clinical progression is defined as: commencement (PACE-B) or re-commencement (PACE-C) of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases

Urinary incontinence assessed by the number of absorbent pads required per day to control leakage measured by The Expanded Prostate Cancer Index (EPIC) questionnaire.

Bowel bother assessed by summary score from the EPIC questionnaire.

CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).

CTCAE and RTOG (SBRT and conventional RT patients only).

Assessed using International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), Vaizey score, and Expanded Prostate Index Composite-26 (EPIC-26) instruments.

Radiographic, clinical or biochemical evidence of local or distant failure

LHRH analogues, anti-androgens, orchidectomy

Biochemical progression is defined as: Phoenix definition (SBRT arm) or \>0.2ng/ml (surgical arm)

Clinical progression is defined as: commencement of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prostate Advances in Comparative Evidence	NCT01584258	Prostate Cancer	Prostatectomy Conventionally ... Prostate SBRT	18 Years -	Royal Marsden NHS Foundation Trust
Prostate Advances in Comparative Evidence	NCT01584258	Prostate Cancer	Prostatectomy Conventionally ... Prostate SBRT	18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for conventionally fractionated prostate radiotherapy