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NCT Number: NCT04858880

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jönköping County Hospital, Ryhov, Jönköping, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Failure-free survival (FFS).

    Time frame: 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

    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.

Secondary outcomes

  1. Systemic treatment-free survival.

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

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

  2. Distant metastasis-free survival.

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

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

  3. Prostate cancer specific survival.

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

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

  4. Overall survival.

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

    Arms A and B will be compared regarding overall survival.

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

    Time frame: Up to 3 months after end of salvage radiotherapy.

    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.

  6. Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy).

    Time frame: After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.

    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.

  7. Patients self-esteem of quality of life.

    Time frame: Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ-C30. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm B), month 12, 24, and 60.

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

  8. Patients self-esteem of quality of life.

    Time frame: Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Adalsteinn Gunnlaugsson, MD, PhD

CONTACT

[email protected]

+46 46 17 75 20

Jan Sundberg, RN

CONTACT

[email protected]

+46 4617 70 34

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

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

Acronym: PROPER2

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Apr 26, 2021
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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