Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

NCT04858880 | Recruiting DMC

• 1 other identifier: PRO-02
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Prostate-Specific Antigen PSA; PSA; Radiation; Lymph node radiation; Prostate cancer recurrence; Randomized trial; Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Failure-free survival (FFS).

  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.

  FFS after SRT, with failure defined as either biochemical or clinical recurrence (imaging or biopsy confirmed). FFS is calculated from the randomization date (arms A and B) until end of follow up (month 60 after

Secondary Outcomes (8)

• Systemic treatment-free survival.

  Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).

• Distant metastasis-free survival.

  Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).

• Prostate cancer specific survival.

  Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).

• Overall survival.

  Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).

• Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy).

  Up to 3 months after end of salvage radiotherapy.

Study Arms (3)

Continued salvage radiotherapy + lymph node irradiation (non responders)

EXPERIMENTAL

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.

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

Continued salvage radiotherapy (non responders)

ACTIVE COMPARATOR

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.

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

Continued salvage radiotherapy (responders)

NO INTERVENTION

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.

Interventions

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

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.

Continued salvage radiotherapy (non responders); Continued salvage radiotherapy + lymph node irradiation (non responders)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only patients with prostate cancer are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Metastases (regional lymph nodes or distant)\* diagnosed with imaging.
• Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone).
• Prior radiotherapy to the pelvis.
• Prior malignancy other than prostate cancer and basalioma in the past five years.
• Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure.
• Severe pulmonary disease.
• Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (3)

Jönköping County Hospital, Ryhov

Jönköping, 551 85, Sweden

RECRUITING

Kalmar County Hospital

Kalmar, 391 26, Sweden

RECRUITING

Lund University Hospital

Lund, 221 85, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Adalsteinn Gunnlaugsson, MD, PhD

CONTACT

+46 46 17 75 20; adalsteinn.gunnlaugsson@skane.se

Jan Sundberg, RN

CONTACT

+46 4617 70 34; jan.sundberg@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 26, 2021
• Study Start: April 9, 2021
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)