Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

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.

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.

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.

Radiation to the prostate bed with or without addition of radiation of lymph node irradiation (non responders). Patients with PSA response continues radiotherapy as initially planned, and are not followed according to the study protocol, only according to clinical practice.

Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.

Adalsteinn Gunnlaugsson, MD, PhD

Jan Sundberg, RN

Kirsten Björnlinger, MD

Nandor Vass, MD

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.

Only patients with prostate cancer are eligible.

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

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

Failure-free survival after salvage radiotherapy (SRT), with failure defined as either biochemical, defined as verified PSA level of ≥ 0.2 ng/ml above the post-radiotherapy PSA nadir value or clinical Recurrence, imaging or biopsy confirmed.

Arms A and B will be compared regarding systemic treatment-free survival.

Arms A and B will be compared regarding distant metastasis-free survival. survival.

Arms A and B will be compared regarding prostate cancer specific survival survival.

Arms A and B will be compared regarding overall survival.

Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.

Arms A and B will be compared regarding quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.	NCT04858880	Prostate Cancer	Radiation to th...	18 Years -	Lund University Hospital
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.	NCT04858880	Prostate Cancer	Radiation to th...	18 Years -	Lund University Hospital
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.	NCT04858880	Prostate Cancer	Radiation to th...	18 Years -	Lund University Hospital

Spots Global Cancer Trial Database for lymph node radiation