Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

Summary

This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate.

One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery.

A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted.

Conditions

• Prostatic Neoplasms

Interventions

PROCEDURE

Prostatectomy/Surgery

Radical prostatectomy with or without adjuvant or salvage radiotherapy

OTHER

Radiotherapy with adjuvant androgen deprivation therapy

Radiotherapy with adjuvant androgen deprivation therapy

Sponsors & Collaborators

• Olof Akre

  lead OTHER

Principal Investigators

• Johan Stranne, M.D ass prof · Sahlgrenska University Hospital, Department of Urology, SE- 413 45 Gothenburg

• Camilla Thellenberg Karlsson, MD, PhD · Umeå University Hospital, Department of Radiation Science, SE-901 87 Umeå Sweden

• Eva M Johansson, R.N PhD · Karolinska Institute, Nobelsväg, SE- 171 77 Solna, Sweden

• Gunnar Steineck, M.D Prof · Karolinska Institute, Nobelsväg, SE-171 77 Solna, Sweden

• Klaus Brasso, M.D · Rigshospitalet, department Urology, DK-2001-Copenhagen, Denmark

• Peter M Meidahl Petersen, M.D ass prof · Rigshospitalet, Region h, Department of Oncology, Blegdamsvej 9, DK- 2001, Copenhagen, Denmark

• Bjørn Brennhovd, M.D ass.prof · Oslo University Hospital, Department of Urology, P.O Box 4950 Nydalen, N-0424, Oslo Norway

• Wolfgang Lilleby, M.D ass.prof · Oslo University Hospital, Department of Radiation Therapy, P.O Box 4950, N-0424, Nydalen Oslo, Norway

• Antti Rannikko, M.D ass.prof · Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland

• Mauri Kouri, M.D PhD · Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland

• Tuomas Mirtti, M.D PhD · Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2025-12-31

Completion

2045-12-31

Countries

• Denmark
• Finland
• Norway
• Sweden

Study Locations