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International Randomized Study of Laparoscopic Prostatectomy vs Radiosurgery and Conventionally Fractionated Radiotherapy vs Radiosurgery for Early Stage Organ-Confined Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

International Randomized Study of Laparoscopic Prostatectomy vs Radiosurgery and Conventionally Fractionated Radiotherapy vs Radiosurgery for Early Stage Organ-Confined Prostate Cancer


Inclusion Criteria:



- Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy
cores taken.

- Gleason score ≤ 3+4

- Men aged ≥18

- Clinical and MRI stage T1c -T2c, N0-X, M0-X

- PSA ≤ 20 ng/mL

- Pre-enrollment PSA must be completed within 60 days of registration

- Patients belonging in one of the following risk groups according to the National
Comprehensive Cancer Network:

- Low risk: Clinical stage T1-T2a and Gleason ≤ 6 and PSA < 10 ng/ml, or

- Intermediate risk includes any one of the following:

- Clinical stage T2b or T2c

- PSA 10-20 ng/ml or

- Gleason 7

- WHO performance status 0 - 2

- Prostate volume ≤ 90 cc

- Ability of the research subject or authorized legal representative to understand and
the willingness to sign a written informed consent document

Exclusion Criteria:

- Clinical stage T3 or greater

- Gleason score ≥ 4 + 3

- < 10 prostate biopsies taken

- High risk disease as defined by National Comprehensive Cancer Network (www.nccn.org)

- Previous malignancy within last 5 years except basal cell carcinoma or squamous cell
carcinoma of the skin

- Prior pelvic radiotherapy

- Prior androgen deprivation therapy (including androgen agonists and antagonists)

- Any prior active treatment for prostate cancer

- Life expectancy <10 years

- Bilateral hip prostheses or any other implants/hardware that would introduce
substantial CT artifacts

- Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel
disease, significant urinary symptoms

- Anticoagulation with warfarin or bleeding tendency making fiducial placement unsafe.

- Medical condition/ implant that prohibits MRI

- Comorbidity that excludes surgery (patients can still be entered into radiotherapy
randomization arm)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical disease-free survival

Outcome Description:

Biochemical progression is defined as follows: For conventional radiation and radiosurgery arms: Serum PSA of at least 2 ng/mL greater than the post-radiotherapy nadir (lowest PSA to date)(Phoenix definition); for surgical arm: PSA > 0.2 ng/mL. For either arm, a recommencement of androgen deprivation also counts as biochemical failure.

Outcome Time Frame:

5 years (primary timepoint)

Safety Issue:

No

Principal Investigator

Nicholas van As, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust, London, United Kingdom

Authority:

United States: Institutional Review Board

Study ID:

ACCP003

NCT ID:

NCT01584258

Start Date:

April 2012

Completion Date:

April 2025

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Prostate adenocarcinoma
  • Early stage prostate cancer
  • Organ-confined prostate cancer
  • Low-risk prostate cancer
  • Intermediate-risk prostate cancer
  • Prostatic Neoplasms

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