Prostatectomy Clinical Trials

Clinical trials related to Prostatectomy Procedure

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.

Who is this study for? Adult patients with prostate cancer
What treatments are being studied? Radiation to the prostate bed with or without addition of radiation of lymph node irradiation
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA \<0.70 ng/ml) after prostatectomy.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Life expectancy \> 10 years

• Age ≥18 years.

• World Health Organization (WHO) performance status 0-1.

• Estimated life expectancy \>10 years.

• Histological evidence of prostate cancer in the prostatectomy specimen

• Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M0.

• Biochemical Recurrence (BCR) after prostatectomy, with 0.15 ≤ PSA \<0.70 ng/ml.

• Patients must be able to comply with the protocol.

• Signed informed consent.

• Adequate laboratory findings (Haemoglobin (Hb) \>90g/L, absolute neutrophil count \>1.0x109/L, platelets \>75x109/l, bilirubin \<1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) \<5x ULN and creatinine \<1.5 ULN).

Locations
Other Locations
Sweden
Jönköping County Hospital, Ryhov
RECRUITING
Jönköping
Kalmar County Hospital
RECRUITING
Kalmar
Lund University Hospital
RECRUITING
Lund
Contact Information
Primary
Adalsteinn Gunnlaugsson, MD, PhD
adalsteinn.gunnlaugsson@skane.se
+46 46 17 75 20
Backup
Jan Sundberg, RN
jan.sundberg@skane.se
+46 4617 70 34
Time Frame
Start Date: 2021-04-09
Estimated Completion Date: 2030-04
Participants
Target number of participants: 374
Treatments
Experimental: Continued salvage radiotherapy + lymph node irradiation (non responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
Active_comparator: Continued salvage radiotherapy (non responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
No_intervention: Continued salvage radiotherapy (responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice.
Related Therapeutic Areas
Prostate Cancer
Prostatectomy
Sponsors
Leads: Lund University Hospital

This content was sourced from clinicaltrials.gov

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